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FDA Warns Tianjin of Significant Deviations in API Facility Operations

Strategic Insights

— 1 min read

The US FDA issued a warning letter to the Tianjin-based company on December 14, citing multiple significant deviations from Good Manufacturing Practice (GMP) regulations. The warning letter highlighted inadequate validation of analytical methods for detecting residual solvents, poor equipment design and maintenance, and a lack of process validation. The agency also expressed concerns over the company's inability to correct past deviations and bring its API facility into GMP compliance. FDA has stated that it will not reinspect the firm until it has obtained certification by a consultant and has disapproved any applications listing the firm as a supplier.

Key Takeaways:

  • The FDA warning letter cited 20 items (483) related to inadequate validation of analytical methods and equipment design and maintenance issues.
  • The company's process validation for an unnamed product did not define all significant processing steps/parameters and was based only on laboratory data review.
  • The FDA rejected Tianjin's proposal for retrospective validation, stating that it demonstrated a lack of understanding of process validation principles.
  • Retrospective validation may be useful for well-established processes with no significant changes to API quality, but Tianjin's case does not meet this criteria.
  • The company's five-year history shows an unwillingness to carry out corrections and bring its API facility into GMP compliance.
  • The FDA will not reinspect the firm until it has obtained certification by a consultant and has disapproved any applications listing the firm as a supplier.
  • Tianjin's products will be detained by the FDA.

Statistics:

  • 20: The number of items cited in the FDA warning letter (483).
  • 1999: The year in which the FDA issued a warning letter for significant deviations from GMP's in production of both APIs.
  • 5 years: The length of time in which the company has been unable to correct past deviations and bring its API facility into GMP compliance.

Sources:

  • FDA Warning Letter (December 14)
  • FDA Warning Letter Bulletin database
  • FDA regulations (21 CFR 211)

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