FDA Inspection
Unichem Laboratories LimitedUnichem Laboratories Limited – FDA Inspection, Jun 29, 2018
Record Details
This FDA Inspection record concerns Unichem Laboratories Limited, with an inspection on June 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3c5aa298-36ef-4efa-8a4a-fb6512edaeec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057350
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(j)Failure to maintain records
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