OBJECTIVES

The US FDA may apply enforcement actions, including warning letters, to ensure regulatory compliance. A warning letter expresses the FDA assessment of compliance of a company with the law, describes the violation observed, provides a citation of the statutory provision, and, if applicable, the regulation violated. This study assessed the FDA warning letters of 2018 and evaluated violations of current good manufacturing practices (CGMP) regulations in FDA warning letters of 2018.

METHODS

: The data derived from the FDA website. The study included warning letters released by the Center for Drug Evaluation and Research (CDER). The warning letters contain information about the FDA office releasing the letter, date, product/issue, issue date, the reason for the letter, and specific violation by the CFR. Descriptive statistical analysis was conducted for the study.

RESULTS

: In 2018, the FDA released 422 warning letters to companies of which and 91 (21.5%) were released by CDER. There were 61 (67.0%) warning letters that alerted pharmaceutical companies about lack of compliance with CGMP regulation, including 45 (73.8%) related to finished pharmaceutical products and 16 (26.2%) to active pharmaceutical ingredients. CDER letters contained a total of 198 CGMP deviation, of which 156 (78.8%) were linked to a specific regulation contained in the Code of Federal Regulations (CFR), and 42 (21.2%) did not mention a specific regulation. The most common reported CGMP violations related to 21 CFR part 211, subpart I, laboratory controls (43 violation, 21.7% of the total).

CONCLUSIONS

: More than half of CDER’s warning letters addressed to pharmaceutical companies related to CGMP. The majority of CGMP warning letter was for finished products. The warning letters included multiple violations of federal regulation. Laboratory controls was the most common deviation mentioned in the letters.