FDA Inspection
Vikas Laboratories Pvt. Ltd.Vikas Laboratories Pvt. Ltd. – FDA Inspection, Aug 31, 2016
Record Details
This FDA Inspection record concerns Vikas Laboratories Pvt. Ltd., with an inspection on August 31, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Vikas Laboratories Pvt. Ltd.
- Inspection Date
- August 31, 2016
- Product Type
- Drugs
View Company Profile
ID · 2ab391e1-18db-4c69-8905-712dcb2a40d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986022
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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