FDA 483 - SCA Pharmaceuticals, Inc. - May 17, 2023

The FDA inspection of an unnamed facility revealed significant deficiencies in aseptic processing areas and quality control.

**Environmental Monitoring Deficiencies:** * The firm lacks a scientifically sound environmental monitoring plan, including appropriate sampling frequency and timing. * Documentation does not demonstrate representative environmental sampling. * Viable active air samples are taken infrequently (e.g., one per four hours or lot, with discretion on timing). * Continuous non-viable particle monitoring in ISO 5 Laminar Flow Hoods is not activated until after critical connections, omitting earlier activities like vial preparation and admixing.

**Air Supply and Cleanroom Design Issues:** * ISO 7 Cleanroom 902, where critical operations occur, has issues with its ISO 5 Laminar Flow Hoods (Hood #s (b)(4)). * Certification reports for these hoods (dated (b)(4) and (b)(4)) lack measurements of unidirectional air velocity near the work surface. * Air return vents in Room 902 are frequently obstructed by items like carts, tables, and trash receptacles, as demonstrated by a July 6-7, 2022 smoke study and observed during inspection.

**Failure to Investigate Discrepancies:** * The firm failed to thoroughly review unexplained discrepancies. * On May 3 and May 5, 2023, environmental monitoring plates for passive air monitoring in ISO