Trends In 2020 FDA Pharma Warning Letters

by | Jul 16, 2021 | CFR, Compliance, Enforcement Actions, FDA, GMP, Pharmaceuticals, QMS, Quality, Quality Systems, Supplier Management, Testing, Warning Letter

The recent trend of U.S. Food and Drug Association citations issued to those operating in the pharmaceutical manufacturing arena offer grave concern over data integrity, the inadequacy of qualifying supplier certificates of analysis (CoAs), and ineffective discrepancy investigations leading to skepticism over drug purity. FDA citations known as warning letters are a reliable mode of action the agency elects to take for notifying companies and the public of substantial violations against the Code of Federal Regulations Title 21 (CFR 21) uncovered during an inspection.

Observing common themes shared between companies who were issued warning letters related to drug good manufacturing practices (GMP) might show trends highlighting areas of improvement for a robust Quality Management System. Sarah B. Tanksley, MS, and Audrey Francis1 published an article analyzing 33 compiled warning letters from 33 companies during the timeframe of January 1st thru August 10th of 2020.  

The majority of identity and purity-related citations were levied upon over-the-counter (OTC) drug producers, specifically for lackluster implementation and management of current good manufacturing practice controls. Even inexcusable violations were consistently present for OTC manufacturers, such as no utilization of any quality system. A recent focus for the FDA has been on component origin and quality due to concerns centered around drug purity in the latest discoveries of nitrosamine contamination in several widely used drugs. Furthermore, 12 firms in total were explicitly cited for 21 CFR 211.84(d)(1) and/or (2) for failing to test incoming components and verifying conformance of each drug product batch, which is generally labeled as inappropriately qualifying supplier CoAs.  

For non-OTC manufacturers, several examples of data integrity issues were apparent in terms of maintaining accurate records and establishing effective computer controls. This has sparked more attention toward implementing heightened quality control measures in data and records management.

The EMMA International team has procured significant knowledge backed by proven experience helping those comply with GMP, Supplier Management, Record Controls, and all related QA and RA activities. Reach out to our team today at 248-987-447 or email us at to learn about how EMMA can meet your QA and RA needs today!

[1] B. Tanksley MS., Audrey Francis (2020) FDA warning letters in 2020 reveal concerns around purity, investigations, and data integrity. Retrieved on 13 July 2021 from:

Zach Nies

Zach Nies

Quality Engineer (Co-Op) - Mr. Nies has experience in combination products, pharmaceuticals, and FDA compliance for many life science industries. He has experience with many different elements of quality and regulatory compliance. Mr. Nies is completing a Bachelor of Engineer degree in Biomedical Engineering from Wayne State University.

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