FDA Inspection
Milan Laboratories (India) Pvt LtdMilan Laboratories (India) Pvt Ltd – FDA Inspection, Aug 4, 2017
Record Details
This FDA Inspection record concerns Milan Laboratories (India) Pvt Ltd, with an inspection on August 4, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 948cca1c-a29b-4058-b709-7720b0242a43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021237
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.52Washing and toilet facilities are deficient
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