FDA Inspection
Vovantis Laboratories Private LimitedVovantis Laboratories Private Limited – FDA Inspection, Jun 9, 2017
Record Details
This FDA Inspection record concerns Vovantis Laboratories Private Limited, with an inspection on June 9, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · edbbc3c0-0ca7-4f6e-a072-013854779b33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015159
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Vovantis Laboratories Private Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Vovantis Laboratories Private Limited
- FDA Inspection 1243740 - 2024-05-24
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