An Analysis Of Recent CDER Observation & Warning Letter Data

By Barbara Unger, Unger Consulting Inc.

Each spring, the FDA publishes data on its website related to Form 483 inspection observations and warning letters issued by the Center for Drug Evaluation and Research (CDER) during the previous fiscal year. By analyzing this annual data — and comparing it to that of other recent fiscal years — pharmaceutical and biopharmaceutical manufacturers can gain a clearer picture of FDA enforcement trends and their potential impact on business and the industry as a whole.

In this article, we will compare results from the FDA’s 2015 fiscal year with results from fiscal years 2013 and 2014. We will start with the inspection observations and determine which were the most common citations, providing potential reasons for obvious changes in 2015 over previous years. It is important to note that the data published on the FDA website represents only Form 483s that were reported via the FDA’s Turbo EIR automated reporting system — manually prepared 483s are not published online and thus are not part of my analysis.

After reviewing the inspection observations, we will move on to CDER GMP warning letters from the same time period and look at product category, geography, and trends in deficiencies that are cited. Appendices 1 through 3 provide listing and links to the warning letters for each of the fiscal years.

High-Level Analysis

The annual number of CDER inspection observations did not change significantly between FY 2013 and FY2015, even though there are some slight increases in the frequency of certain observations. These changes may represent an increased focus on compounding pharmacies and outsourcing facilities, though data is not available to confirm this theory. Remember that this data does not include all 483 observations, only those prepared within the Turbo EIR system.

Drug GMP warning letters issued to compounding pharmacies increased dramatically from FY2013 to FY2014 and 2015. This represents an unusual enforcement focus on a single segment of the drug industry. FDA’s legal authority over these entities was clarified in the Compounding Quality Act, part of the Drug Quality and Safety Act signed into law in November 2013, and explains the apparent explosion of enforcement action.  FDA Office of Regulatory Affairs (ORA) statistics show that approximately 3% of inspections result in warning letters, but for compounding pharmacies and outsourcing facilities the value is close to 40%, according to Lachman Consultants.

The number of warning letters issued to non-compounding pharmacy sites in the U.S. decreased dramatically during the same period. The number of warning letters issued to sites outside the U.S. (OUS) has also decreased since FY2013.  Enforcement focus seems to be sharply focused on compounding pharmacies at the possible expense of both U.S. and OUS pharma sites. (See Tables 2 and 3, Figures 3, 4, and 5)

Between FY 2013 and 2015, many of the warning letters issued regarding sites located outside the U.S. identified deficiencies in data integrity / data management. I will explore this trend — along with a review of recent data integrity-related guidances from FDA and the World Health Organization (WHO) — in my next article.

Inspection Observations

The following data is based on inspections generated using the FDA Turbo-EIR system.  Data from inspections of API manufacturers and form 483s generated outside the system are not included.  Data in the Table 1 is collated based on data from the FDA website with one difference. Some citations, such as 21 CFR 211.192, are actually divided into several line items throughout the FDA tables; I’ve consolidated them into a single line item.  The same change has been made for each of the line items.

When the numbers are consolidated, it is obvious that problems with the topic of “production record review” and “investigation of any unexplained discrepancy” are at the top of the list. As a result, 211.192 moves from third on the FDA list this year and in 2014 to first when all subsets are consolidated — see Table 1. In FY2013, FDA’s tabulation lists 211.192 as second, but again, if all subsets are consolidated it becomes first.Table 1 shows only the most frequent group of inspection observations; the FDA tabulation shows all.

Table 1: Most Common Inspection Observations (2013-2015)

Citation	Short Description	2015	2014	2013
211.192	Production record review, investigations of discrepancies	250	209	239
211.160(b)	Development of scientifically sound specifications	246	165	199
211.42(c)	Requirement for adequate facilities to prevent contamination or mix-ups	235	125	94
211.22(d)	Quality unit responsibilities shall be in writing and should be followed	165	148	168
211.113(b)	Validation of aseptic processes including sterilization	157	109	119
211.166(a)	Expiration dating shall be supported by appropriate studies	126	82	104
211.100(a)	Written procedures shall describe production and process controls	123	107	135
211.25(a)	Staff shall have training, education, and experience to perform their jobs	119	115	132
211.67(a)	Equipment shall be cleaned and maintained	113	94	71
211.188	Batch production records	110	74	114
211.67(b)	Procedures shall describe cleaning and maintenance of equipment	91	80	83
211.110(a)	Processes shall be validated	85	74	79
211.165(a)	Specifications shall be established for drug product	80	64	66
211.68(a)	Automatic equipment including computers shall be routinely calibrated and inspected	72	64	69
211.100(b)	Activities shall be documented at the time of performance	72	62	84

Figure 1 shows the above group of inspection observations graphed over the three fiscal years.  While there is some variation from year to year, the frequency with which specific regulations are identified remains fairly constant. 

Figure 2 shows additional detail of several areas where the frequency of the observation was higher in FY2015 than in the two previous years.  This change could be due to the specific form 483s that were generated within the Turbo-EIR system. Alternatively, it’s possible that they are due to FDA’s intense focus on compounding pharmacy and outsourcing facility inspections. Many of these facilities have inspection observations in these four areas:  the absence of scientifically sound specifications, lack of appropriately segregated facility areas to prevent contamination, lack of validation of aseptic processes including sterilization, and expiry dating that is not supported by stability data.  It is impossible to know the real reason why the frequency of these citations has increased.

In conclusion, there is little change in the overall frequency of inspection observations, as characterized by the regulation cited, between FY2013 and 2015. The most frequent observations cite 211.192 (investigations), 211.160(b) (scientifically sound specifications) and 211.42(c) (validation of aseptic processes including sterilization).   Where increases in specific observations are noted in Figure 2, it may be due to FDAs focus on inspections of compounding pharmacies and outsourcing facilities, for which these are frequent observations. Data is not available to validate this possible conclusion.

For those interested in a deeper dive into FDA FY2015 inspection observations, please see the LinkedIn article Trend Analysis of 2015 FDA Inspection Data: DRUGS.

Drug GMP Warning Letters

In this section, we turn to drug GMP warning letters in FDA fiscal years 2013 through 2015.  Appendices 1 through 3 provide tabulations of warning letters from each of the three years that identify product type covered in the letter, the issuing office, number of deficiencies identified, and the country in which the sites in question are located.  Links to each of the warning letters are also provided.

Table 2 shows that the number and percent of warning letters issued to compounding pharmacies increased dramatically between FY2013 and FY2015.  This represents an unusual enforcement focus on a single segment of the pharmaceutical industry.  FDA’s legal authority over these entities was clarified in the Drug Quality Security Act (DQSA) legislation, signed in November 2013, and explains the apparent explosion of enforcement action.  Most of the compounding pharmacies that received these warning letters manufactured sterile injectable products.  When removing compounding pharmacies from consideration, Table 2 also shows a dramatic drop in official enforcement actions against pharmaceutical firms in the U.S. and a continued focus on sites OUS. The numbers and percentage, however, have decreased since FY2013.  This is perhaps due to the focus on the domestic compounding pharmacy industry.  

Table 2: Drug GMP Warning Letters

	FY2013	FY2014	FY 2015
Total	41*	49**	42
Compounding pharmacies	3 (7%)	27 (55%)	24 (57%)
U.S. (non-compounders)	13 (32%)	4 (8%)	3 (7%)
OUS	25 (61%)	18 (37%)	16 (38%)
API sites	5	8	9
Drug product (non-compounders)	29	12	9
API and drug product	3	2	1

* Includes one repackager not counted as either API or drug product

** Includes one warning letter regarding combination products, considered drug product

The involvement of API sites in warning letters has almost doubled since FY2013.  The number of non-compounding drug product sites has decreased by over half, again likely due to the FDA’s focus on compounding pharmacies and outsourcing facilities.  As the percentage of warning letters issued to compounding pharmacies has increased, those issued to pharmaceutical manufacturers both inside and outside the U.S. has diminished.  This seems to represent FDA’s allocation of its limited inspection resources. Figure 3 shows the high-level data presented in Table 2. 

Figure 4 shows data regarding type of manufacturing site associated with warning letters, excluding compounding pharmacies.  The focus on API sites has increased and the number of drug product sites has diminished over the time period.

 

Table 3 shows the geographic distribution of warning letters issued outside the U.S.  European countries are counted together since only in one year, FY2013, did any of the countries receive more than one warning letter. European area countries included over the three years include Ireland, Spain, Czech Republic, Italy, Portugal, Denmark, Austria, Netherlands, and Germany. The decrease in warning letters issued to European sites may represent an “unofficial” reliance on EMA inspections of sites located in this area, even in the absence of an official mutual recognition agreement (MRA). 

Table 3: Drug GMP Warning Letters Issued Regarding Sites Outside the U.S.

Country / Geography	FY2013	FY2014	FY2015	TOTAL
India	7	7	8	22
Europe	7	3	3	13
China	2	4	2	8
Canada	4	1	1	6
Taiwan	1			1
Hong Kong		1		1
Australia	1	1		2
New Zealand			1	1
Jamaica	1			1
Japan	2			2
Mexico		1		1
Thailand			1	1

India received the highest number of warning letters issued to a single country, with China coming in second.  Over this time period, inspections in China have been limited by the number of visas issued to FDA investigators.  Thus, one should not assume the industry in India has more problems than the industry in China.  For those who like graphs rather than tables (like me!), Figure 5 shows the same information as Table 3.

Drug GMP Inspection To Warning Letter Issuance Intervals

Last year seemed to show an increase in the interval between inspection and warning letter issuance.  Here we provide several years-worth of data to demonstrate this is generally true, with a couple of exceptions.  We start with FY2013 and include 1HFY2016.  Data is provided for the total number of warning letters, those issued to compounding pharmacies / outsourcing facilities, pharma firms in the US and outside the US.  When two or more inspections were mentioned in a warning letter, I took the date nearest to the warning letter issued, under the assumption (perhaps incorrect) that the final inspection provided the incentive that made the warning letter issuance appropriate.   When tabulating the individual intervals, they are rounded to the nearest half month. 

Table 4 shows the interval between inspections and warning letter issuance for the fiscal years in question.  Figure 6 provides a graphic representation of the data.  Also see Table 1 for the number of warning letters in each of the FY categories.

Table 4:  Interval Between Inspection and Warning Letter in Months

	FY2013	FY 2014	FY2015	1H FY 2016
TOTAL WLs	6.7	8.8	10.3	12.4
Compounding Pharmacies	3.7	10.5	10.8	12.5
US sites (non-compounders)	8.3	7.1	4.5	12.6
OUS	6.4	6.5	10.6	12.3

In conclusion:

• The average interval between inspection and issuance of all warning letters, and those issued outside the U.S. (OUS), almost doubled between FY2013 and 1HFY2016.
• The average time to warning letter issuance for all drug manufacturer categories, including compounding pharmacies / outsourcing facilities, exceeded 12 months in 1HFY2016.
• The near-doubling of time between inspection and warning letters issued to sites outside the U.S. between FY2014 and 1HFY2016 is dramatic.  It is not clear why this is the case.  In many of these cases, the warning letters acknowledge that the firms hired third-party consultants to assist in remediation of inspection observations.
• The exception to the increase in time interval is sites in the U.S., likely due to their limited number.  FY2014, FY2015, and 1H FY2016 saw four, three, and four warning letters respectively issued to sites in the U.S.  FY2013 saw 13 warning letters. The very short duration between inspections and issuance of warning letters for compounding pharmacies in FY2013 was likely due to their small number (three in this case).

Product Type	Issue Date	Company Name	Issuing Office	Number of Deficiencies	Country
Repackager	10/9/2012	Stat Rx US	Atlanta	3	USA
Drug product	10/23/2012	International Laboratories Ltd.	Center	5	Canada
Drug product	11/14/2012	Shanghai Huhui Daily Use Chemical Products Co., Ltd	Center	6	China
Drug product	12/12/2012	Novo Nordisk A/S	Center	2	Denmark
Drug product	12/17/2012	Hameln Pharmaceuticals GmbH	Center	3	Germany
Drug product	12/17/2012	Taiwan Three Mast Pharmaceutical Co Ltd.	Center	5	Taiwan
Drug product	1/10/2013	Physicians Total Care, Inc.	Dallas	5	USA
Drug product	1/29/2013	Sovereign Pharmaceuticals, LLC	Dallas	2	USA
Drug product	1/29/2013	P.A. Benjamin Manufacturing Co., Ltd.	Center	6	Jamaica
Drug product	2/14/2013	Laclede Inc	Los Angeles	3	USA
API	2/19/2013	Abbey Color Inc	Philadelphia	3	USA
Drug product	2/20/2013	Jubilant HollisterStier General Partnership	Center	3	Canada
Drug product	2/21/2013	Apotex Inc	Center	5	Canada
Compounding pharmacy	3/7/2013	Medi-Fare Drug and Home Health Center	Atlanta	6	USA
Drug product	3/18/2013	Keystone Laboratories Inc	New Orleans	5	USA
API	3/22/2013	Alexion Pharmaceuticals	New England	2	USA
API	3/22/2013	Asada Milling Co., Ltd	Center	6	Japan
Drug product	3/22/2013	Peking Medicine Manufactory	Center	5	China
Drug product	3/27/2013	Wyeth Lederle (Pfizer)	Center	2	Italy
Drug product	4/1/2013	Kanebo Cosmetics Inc	Center	4	Japan
Drug product	4/25/2013	CMI Cosmetic Manufacturers	Center	3	Canada
Drug product	4/26/2013	V-SAB Medical Labs	Atlanta	4	USA
API and drug product	5/6/2013	Boehringer Ingelheim	Center	4	Germany
Compounding pharmacy	5/15/2013	Custom Compounding Centers	Los Angeles	5	USA
Drug product	5/17/2013	Contract Pharmaceutical Services	Center	3	Australia
Drug product	5/28/2013	Ebewe Pharma (Novartis)	Center	2	Austria
API and drug product	5/28/2013	RPG Life Sciences Limited	Center	7	India
Drug product	5/31/2013	Baxter Healthcare	Atlanta	5	USA
API	7/1/2013	Fresenius Kabi Oncology Limited	Center	4	India
Drug product	7/2/2013	Cispharma Inc.	New Jersey	4	USA
API and drug product	7/3/2013	Aarti Drug Limited	Center	4	India
Drug Product	7/18/2013	Wockhardt Limited	Center	6	India
API	8/2/2013	Posh Chemicals Private Limited	Center	3	India
Drug product	8/9/2013	Promed Exports Private Limited	Center	2	India
Drug product	8/16/2013	Fenwal, a Fresenius Kabi Company	San Juan	4	USA (PR)
Compounding pharmacy	8/21/2013	Stewart Compounding Pharmacy	Atlanta	6	USA
Drug product	8/22/2013	Jabones Pardo S.A.	Center	5	Spain
Drug product	8/29/2013	Sanquin Plasma Medical Products	Center	21	Netherlands
Drug product	8/30/2013	Lloyd Inc of Iowa	Kansas City	7	USA
Drug product	9/4/2013	Allergy Laboratories Inc	Center	5	USA
Drug product	9/9/2013	Agila Specialties Private Limited	Center	7	India

 

Appendix 2: Drug GMP Warning Letters, FY2014

Product Type	Issue Date	Company Name	Issuing Office	Number of Deficiencies	Country
Drug product	11/25/2013	Wockhardt Limited	Center	4	India
Drug product	11/27/2013	Jubilant HollisterStier, LLC	Seattle	2	USA
Drug product	12/2/2013	Ameriderm Laboratories, Ltd.	New Jersey	6	USA
Compounding pharmacy	1/14/2014	Avella of Deer Valley	Los Angeles	3	USA
Compounding pharmacy	1/14/2014	Triangle Compounding	Atlanta	6	USA
Compounding pharmacy	1/15/2014	Medaus Inc	New Orleans	6	USA
Compounding pharmacy	1/22/2014	Home Intensive Care Pharmacy	Dallas	5	USA
Combination product	1/27/2014	Amgen Inc.	Los Angeles	3	USA
API	1/31/2014	CBSCHEM Limited	Center	6	Hong Kong
Drug product	6/2/2014	USV Limited	Center	2	India
Compounding pharmacy	2/14/2014	Nora Apothecary Pharmacy	Detroit	5	USA
Compounding pharmacy	2/18/2014	Olympia Pharmacy	Florida	6	USA
Compounding pharmacy	2/19/2014	Pallimed Solutions Inc	New England	7	USA
Compounding pharmacy	2/21/2014	Wedgewood Village Pharmacy	New Jersey	8	USA
API	2/27/2014	Canton Laboratories Private	Center	4	India
Compounding pharmacy	2/28/2014	Village Fertility Pharmacy	New England	4	USA
Compounding pharmacy	2/28/2014	Total Pharmacy Services Inc	New Orleans	6	USA
API	3/6/2014	Smuthri Organics Limited	Center	3	India
Compounding pharmacy	3/7/2014	Pentec Health	Philadelphia	2	USA
Drug product	3/18/2014	SmithKline Beecham	Center	3	Ireland
API/drug product	4/11/2014	SANUM-Kehlbeck GmbH & Co KG	Center	6	Germany
Drug product	4/16/2014	Instituto Bioclon	Center	15	Mexico
Drug Product	4/21/2014	Greer Laboratories	Center	8	USA
Compounding pharmacy	4/30/2014	Blue Ridge Pharmacy	Atlanta	8	USA
Compounding pharmacy	5/2/2014	Grandpa's Compounding Pharmacy	San Francisco	5	USA
Compounding pharmacy	5/2/2014	Brookfield Prescription Center	Minneapolis	7	USA
API and drug product	5/7/2014	Sun Pharmaceuticals	Center	5	India
Compounding pharmacy	5/9/2014	Nature's Pharmacy and Compounding Center	Atlanta	7	USA
Compounding pharmacy	5/27/2014	Oakdell Pharmacy Inc	Dallas	6	USA
Compounding pharmacy	6/6/2014	Lee and Company	Dallas	3	USA
API	6/10/2014	Tianjin Zhongan Pharmaceutical Co Ltd	Center	3	China
Drug product	6/12/2014	ID Biomedical Corp (GSK subsidiary)	Center	5	Canada
API	6/16/2014	Apotex Pharmachem India Pvt Ltd	Center	4	India
Compounding pharmacy	6/23/2014	Pharmacy Creations	New Jersey	8	USA
Compounding pharmacy	6/27/2014	Clinical Specialties Compounding Pharmacy	Atlanta	1	USA
Compounding pharmacy	7/7/2014	JCB Labs LLC	Kansas City	1	USA
API	7/7/2014	Trifarma S.p.A.	Center	3	Italy
Drug product	7/8/2014	Marck Bioscience Ltd.	Center	6	India
API	7/9/2014	Zhejiang Jiuzhou Pharmaceutical Co Ltd	Center	4	China
Compounding pharmacy	7/14/2014	RC Compounding Services	Cincinnati	1	USA
Compounding pharmacy	7/18/2014	PharMEDium Services LLC	Chicago	12	USA
Compounding pharmacy	8/12/2014	The Compounding Shop	Florida	6	USA
Compounding pharmacy, animal drug	8/14/2014	Wickliffe Pharmacy	Cincinnati	1	USA
Compounding pharmacy	8/15/2014	Zion Rx Formulations Services LLC dba Rx Formulations Serv.	Los Angeles	6	USA
Compounding pharmacy	9/4/2014	John W Hollis	New Orleans	7	USA
Drug product	9/19/2014	China Resources Sanjiu Medical and Pharmaceutical Company	Center	4	China
Compounding pharmacy	9/24/2014	Beacon Hill Medical Pharmacy	Detroit	7	USA
Drug product	9/26/2014	Hospira, Mugrave Australia	Center	3	Australia
API	9/29/2014	Beijing Shunxin Medical and BioTechnical	Center	1	China

Appendix 3: Drug GMP Warning Letters, FY2015

Product Type	Issue Date	Company Name	Issuing Office	Number of Deficiencies	Country
API	10/15/2014	Sharp Global Limited	PHS/Center	3	India
API	10/15/2014	Cadila Pharmaceuticals Limited	PHS/Center	3	India
Drug product	10/21/2014	Hikma Farmaceutica	PHS/Center	2	Portugal
Compounding pharmacy	10/23/2014	RX South DBA RX3 Compounding Pharmacy	Baltimore	4	USA
Compounding pharmacy	10/24/2014	Pharmagen Laboratories	New England	4	USA
Compounding pharmacy	10/29/2014	Eastern Pharmacy Inc	Florida	1	USA
Compounding pharmacy	11/11/2014	Wells Pharmacy Network LLC	Florida	6	USA
Cell therapy (drug product)	11/20/2014	New Hope Fertility Center	New York	6	USA
Compounding pharmacy	12/9/2014	Delta Pharma Inc	New Orleans	4	USA
API and dosage form	12/19/2014	Novacyl Wuxi Pharmaceutical Co. Ltd	PHS/Center	4	China
Drug product	1/9/2015	Micro Labs Limited	PHS/Center	4	India
Compounding pharmacy	1/21/2015	Cantrell Drug Company	Dallas District	4	USA
Compounding pharmacy	1/27/2015	Oregon Compounding Centers	Seattle	6	USA
Drug product	1/30/2015	Apotex Research Private Ltd	PHS/Center	4	India
Compounding pharmacy	2/13/2015	Pine Pharmacy and Home Care Products Inc	New York	5	USA
API	2/27/2015	Novacyl Ltd. (Thailand)	PHS/Center	3	Thailand
Compounding pharmacy	3/27/2015	Kings Park Slope Inc.	New York	3	USA
Compounding pharmacy	3/27/2015	Alexander Infusion LLC	New York	6	USA
Drug product	3/31/2015	Hospira Spa	Center	4	Italy
Dosage form, PADE + GMP	4/3/2015	Galena BioPharma Inc.	Seattle	2	USA
API	4/6/2015	Yunnan Hande Bio-Tech Ltd	Center	3	China
Compounding pharmacy	4/8/2015	Region Care Inc.	Center	6	USA
Compounding pharmacy	4/14/2015	Leiter's Compounding	San Francisco	6	USA
Compounding pharmacy	4/21/2015	I.V. Specialty, Ltd	Dallas	6	USA
Compounding pharmacy	4/27/2015	Premier Pharmacy Labs Inc.	Florida	6	USA
Compounding pharmacy	4/27/2015	Absolute Pharmacy, LLC	Florida	7	USA
Compounding pharmacy	4/29/2015	Vann Healthcare Services Inc	Cincinnati	6	USA
Compounding pharmacy	5/14/2015	HHCS Pharmac Inc	Florida	4	USA
API	5/27/2015	VUAB Pharma a.s.	Center	2	Czech Republic
Compounding pharmacy	6/4/2015	Green Hills Health and Wellness Pharmacy Inc.	New Orleans	5	USA
Finished pharmaceutical (medical gas)	6/8/2015	Transox Inc	Atlanta	2	USA
Compounding pharmacy	6/17/2015	California Pharmacy and Compounding Center	Los Angeles	5	USA
API	6/22/2015	Attix Pharmaceuticals	Center	1	Canada
Compounding pharmacy	6/25/2015	SCA Pharmaceuticals	Dallas	3	USA
Compounding pharmacy	7/6/2015	KRS Global Biotechnology, Inc	Florida	4	USA
API	7/23/2015	Sipra Labs Limited	Center	2	India
Compounding pharmacy	8/11/2015	Coram Healthcare Corp. of Indiana	Detroit	3	USA
Drug product	8/16/2015	Mylan Laboratories Limited	Center	9	India
Compounding pharmacy	8/31/2015	Specialty Medicine Compounding Pharmacy, P.C.	Detroit	8	USA
API	9/2/2015	Pan Drugs Ltd.	Center	3	India
Dosage form	9/4/2015	Jaychem Industries, Ltd.	Center	4	New Zealand
API	9/28/2015	Unimark Remedies Ltd.	Center	4	India
Compounding pharmacy	9/29/2015	Hieber's Pharmacy	Philadelphia	4	USA

About The Author

Barbara Unger formed Unger Consulting, Inc. in December 2014 to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry. She has extensive expertise in this area having developed, implemented, and maintained the GMP regulatory intelligence program for eight years at Amgen Inc. This included surveillance, analysis, and communication of GMP related legislation, regulations, guidance, and industry compliance enforcement trends. Barbara was the first chairperson of the Rx-360 Monitoring and Reporting work group (2009 to 2014) that summarized and published relevant GMP and supply chain related laws, regulations, and guidance. She also served as the chairperson of the Midwest Discussion Group GMP-Intelligence sub-group from 2010 to 2014.

Before Amgen, Barbara worked for the consulting firm Don Hill and Associates, providing regulatory and quality services to the pharmaceutical industry, and for Eli Lilly and Company in quality and CMC regulatory affairs positions. She began her career in the pharmaceutical / device industry with Hybritech Inc. and received a bachelor's degree in chemistry from the University of Illinois in Urbana Illinois.