fda_483 · inspection_citation · high
SCA Pharmaceuticals LLC -- FDA 483: 4 observations (2024-12-20)
- Event date
- 2024-12-20 00:00:00Z
- Observed
- 2026-07-12 22:32:49Z
- Source ID
- 3013736415-2024-12-20-185240
- Payload hash
- c484d7cac0ae579b2cab31f9…
Summary
Observation 1: There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been ah eady distributed. Specifically, A. Your fnm fail ed to adequately assess and imp...
Entities
Informational only. Not legal, financial, or medical advice.