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Pharmaceutical industry

Thames Pharmacal Faces FDA Scrutiny Over Stability Failures and Field Alert Filings

Strategic Insights

— 1 min read

During a fall 1999 audit, inspectors from the New York District Office uncovered several critical issues at Thames Pharmacal, including stability failures and a dispute over field alert filings. The inspection, which lasted from September 9 to October 14, 1999, resulted in a nine-page 483 and a warning letter dated December 17. The audit focused on the firm's quality control processes, particularly its handling of stability data and field alert reporting.

Key Takeaways:

  • Thames Pharmacal was cited for lacking recorded data in the analyst's notebook for the assay of acetic acid in 24-month stability samples for hydrocortisone 1% and acetic acid 2% otic solution.
  • The firm failed to document the investigation of out-of-specification (OOS) outcomes for stability tests, which resulted in failing results for two lots of HC 1% and AA 2% otic solutions.
  • Thames Pharmacal was also criticized for not issuing a field alert when the 18-month stability assay came in short for two lots of hydrocortisone/acetic acid.
  • The firm's procedures for cleaning equipment were found to be inadequate, leading to the failure to investigate the failure of a piece of equipment in a swab sampling for microbials.
  • Thames Pharmacal revised its SOPs to address the issues raised by the FDA and implemented new procedures for tracking stability tests and investigating OOS outcomes.

Statistics:

  • 24-month stability samples for hydrocortisone 1% and acetic acid 2% otic solution lacked recorded data in the analyst's notebook.
  • Two analysts obtained failing results for the 18- and 24-month stability sample testing of HC 1% and AA 2% otic solutions, but failed to document the investigation.
  • 850% of acetic acid potency tests were below 70% for a pair of lots.
  • The firm recalled all lots that either had not or would not meet their stated expiration dates.
  • Thames Pharmacal paid a fee of $29.50 plus retrieval for the documentation related to the audit.

Sources:

  • "Thames Pharmacal, Ronkonkoma, NY, 9/9-10/14/99, Doc. 108914M, $29.50 plus retrieval."
  • The Checklist - Thames Pharmacal, New York District

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