QuVa Pharma, Inc. – FDA 483, Oct 14, 2022

This FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in quality control, environmental monitoring, aseptic processing, and data integrity.

**Key Observations:**

* **Inadequate Discrepancy Review:** The firm failed to thoroughly review unexplained discrepancies, specifically regarding mold recovery on operator plate samples (June 29, 2022), which was the third such recovery in three months. No documented risk assessment was performed on products produced after these mold recoveries, and affected products were released. * **Insufficient Deviation Investigations:** A deviation investigation (DEIV-06139, Feb 22, 2022) for microbial recovery (Peribacillus simplex/Brevibacterium frigoritolerans) on personnel monitoring plates was inadequate. The investigation did not evaluate room environmental conditions (temperature/humidity), lacked second-person verification of colony counts, and released the affected Oxytocin lot. * **Uninvestigated Environmental Excursions:** Environmental monitoring data for temperature and relative humidity in ISO 7 Cleanrooms were not reviewed, and readings exceeding alarm points (June 27, 29, July 21, 2022) were not investigated, with no incident reports initiated. * **Failure to Initiate Incident Reports:** No incident reports were generated for low pressure gauge readings in an ISO 5 hood or a light brown stain on an ISO 5 hood's