fda_483 · inspection_citation · high
Alps Pharmaceutical Industrial Co., Ltd. -- FDA 483: 2 observations (2025-10-17)
- Event date
- 2025-10-17 00:00:00Z
- Observed
- 2026-07-12 22:31:34Z
- Source ID
- 3002806352-2025-10-17-191592
- Payload hash
- b6b02fa28aa7e898e13d11bd…
Summary
Observation 1: QC laboratory established written procedure for synchronization of laboratory instruments time with the actual time was not followed. For example, QC laboratory SOP: 013-41, Quality Con...
Informational only. Not legal, financial, or medical advice.