FDA Approves Aquitaine Pharm International Despite Deficiencies

Strategic Insights -

Aquitaine Pharm International, a small-volume parenteral (SVP) manufacturer based in Idron, France, has received FDA approval to ship SVPs to the U.S. despite a 483 that highlights the exacting standards of FDA inspectors for environmental monitoring, validation, investigation records, and master batch records. This is the company's second consecutive 483, following a previous audit that resulted in a nine-item 483 focusing on aseptic fill operations and quality control testing.

Key Takeaways:

  • Aquitaine Pharm International received FDA approval to ship SVPs to the U.S. despite a 483 that highlights deficiencies in environmental monitoring, validation, investigation records, and master batch records.
  • The company faced criticism for its use of isolator technology, which FDA inspectors believed did not obviate the need for viable particulate monitoring.
  • FDA disagreed with the company's decision to not validate a change in sterilization load configurations, citing the need for additional testing.
  • The company was faulted for its procedures for documenting investigations into out-of-specification (OOS) in-process events, lacking detail or specificity on corrective measures.
  • Aquitaine presented revised standard operating procedures (SOPs) to the FDA inspectors and translated them before the audit ended.
  • The company implemented all corrections promised after the previous inspection, as confirmed by Dallas district investigator David Beltran.

Statistics:

  • The audit resulted in a 483 with 4 items, including criticism for environmental monitoring, validation, investigation records, and master batch records.
  • FDA inspectors questioned 3 items, including the company's use of isolator technology, sterilization load configurations, and procedures for documenting investigations into OOS in-process events.
  • The company received 2 consecutive 483s, following a previous audit that resulted in a nine-item 483.
  • The inspection was led by Dallas district investigator David Beltran in June 1997.

Sources:

  • Aquitaine Pharm, Idron, France, 6/16-19/97, Doc. 108640M, $7.50 plus retrieval.