Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study

Shray Bablani, Manthan D. Janodia

Research output: Contribution to journalArticle

Abstract

Background: FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. Methods: Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA’s public database. Results: Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. Conclusion: As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products.

Original languageEnglish
JournalTherapeutic Innovation and Regulatory Science
DOIs
Publication statusAccepted/In press - 01-01-2019

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Retrospective Studies
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All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

Cite this

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title = "Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study",
abstract = "Background: FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. Methods: Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA’s public database. Results: Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87{\%} were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72{\%} of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. Conclusion: As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products.",
author = "Shray Bablani and Janodia, {Manthan D.}",
year = "2019",
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N2 - Background: FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. Methods: Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA’s public database. Results: Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. Conclusion: As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products.

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