FDA Audit Reveals Deficiencies in Coulter's Retrovirology Facility

Strategic Insights -

The FDA inspection of Coulter's retrovirology facility in Hialeah, Florida, uncovered several deficiencies, including issues with validation records and product validations. The audit, conducted from April to June 1997, revealed a lack of justification for not using production runs to demonstrate reproducibility and assess variability over time. Additionally, the facility's pouch-sealer validation records were incomplete, and raw data was recorded on loose pages rather than a bound notebook.

Key Takeaways:

  • The FDA audit revealed 25 items on a 483, including several issues with validation records and product validations.
  • The facility had undergone conversion from research to manufacturing HIV-1 p24 antigen kits to meet growing demand.
  • The review of pouch-sealer validation records revealed three deficiencies: a lack of justification for not using production runs, a lack of acceptance criteria for pouches, and raw data recorded on loose pages.
  • Coulter's response outlined its validation efforts and defended its findings, but proposed corrective actions on all counts, including a validation effort with acceptance criteria and improvements to data collection.
  • The FDA faulted product validations for lacking stability studies to assess the HIV-p24 positive control vial closure system.
  • One source of instability identified in July 1996 was a vial closure system that became unstable when stored upside down or sideways.

Statistics:

  • 25 items on the 483, including 3 deficiencies in pouch-sealer validation records.
  • 3 deficiencies in pouch-sealer validation records: a lack of justification, a lack of acceptance criteria, and raw data recorded on loose pages.
  • 37.50 (plus retrieval) was the cost of the document containing the FDA audit results.
  • 4/28-30, 5/1-9, 21, 28, and 6/3/97 were dates of the FDA audit.

Sources:

  • FDA documents, Citation: Coulter, Hialeah, FL, 4/28-30, 5/1-9, 21, 28 and 6/3/97, Doc. 108591M, $37.50 plus retrieval.
  • FDA EIR (Establishment Inspection Report).