fda_483 · inspection_citation · high

Hikal Limited -- FDA 483: 3 observations (2025-02-07)

Event date: 2025-02-07 00:00:00Z
Observed: 2026-07-12 22:32:46Z
Source ID: 3003560263-2025-02-07-191808
Payload hash: 47b932866db9c183ace89994…

Summary

Observation 4: Written procedures are deficient specifically A. Your firm's vendor qualification procedure, CQA01002-0l, indicates that vendors are assessed on the number of consecutive rejections enc...

Entities

Hikal Limited

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Informational only. Not legal, financial, or medical advice.