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Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014

  • Regulatory Science: Original Research
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Abstract

Background

The US Food and Drug Administration (FDA) is responsible for protecting public health. Issuance of a warning letter is the FDA’s principal means of achieving prompt voluntary compliance with regulations. The objective of this study is to analyze the trends of warning letters issued to medical products about current good manufacturing practices (CGMP) violations during 2007–2014, with a secondary purpose of providing suggestions to manufacturers on how to avoid warning letters.

Methods

Warning letters were collected from the FDA website, and information about the date of issuance, company, country, and type of medical product was collected from the letters related to medical products about CGMP violations. Descriptive statistics were performed for the analysis.

Results

A total of 997 warning letters were issued to medical products about CGMP violations during 2007–2014. It showed an upward trend in the number of warning letters from 2009 to 2011. In 2011, it reached a maximum and the FDA released 159 letters. Overall, 685 (68.7%) letters were issued to medical devices, 223 (22.4%) to finished pharmaceuticals, followed by active pharmaceutical ingredients (5.7%), biological products (including blood products) (1.8%), and pharmacy compounding (1.4%). Despite a sharp reduction in 2013, the annual number of warning letters released to medical devices was larger than others; conversely, changes in other products remained relatively stable.

Conclusions

The issuance number of warning letters increased during 2009–2011. Medical device manufacturers received the largest numbers of letters. The issuance number and type of warning letters were greatly influenced by changes in FDA’s internal enforcement procedures, drug policies and regulations, as well as other departments’ regulations. Manufacturers should comply with regulations voluntarily and respond promptly to policy changes.

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Authors and Affiliations

  1. School of Pharmaceutical Science and Technology, Tianjin University, No. 92 Weijin Road, Nankai District, Tianjin, 300072, P. R. China

    Liqing Wang BS, Hang Zheng MS, Xiaohong Ren MS & He Sun PhD

Authors
  1. Liqing Wang BS
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  2. Hang Zheng MS
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  3. Xiaohong Ren MS
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  4. He Sun PhD
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Correspondence to He Sun PhD.

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Wang, L., Zheng, H., Ren, X. et al. Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014. Ther Innov Regul Sci 50, 312–318 (2016). https://doi.org/10.1177/2168479015619201

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