FDA Inspection
USV Private LimitedUSV Private Limited – FDA Inspection, Aug 2, 2017
Record Details
This FDA Inspection record concerns USV Private Limited, with an inspection on August 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d681fdc4-84d7-484b-afa2-8bbf8fb93f17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020024
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.84(d)(3)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.84(d)(3)Establish reliability of supplier's C of A
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Other FDA inspections of USV Private Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 17, 2019 | Not classified | Office of Inspections and Investigations | |
| June 10, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for USV Private Limited
- FDA Inspection 1190842 - 2022-11-17
- FDA Inspection 1106992 - 2019-09-17
- FDA Inspection 972077 - 2016-06-10
- FDA Inspection 927397 - 2015-03-27
- FDA Inspection 850631 - 2013-09-06
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