FDA Inspection
USV Private LimitedUSV Private Limited – FDA Inspection, Nov 17, 2022
Record Details
This FDA Inspection record concerns USV Private Limited, with an inspection on November 17, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- USV Private Limited
- Inspection Date
- November 17, 2022
- Product Type
- Drugs
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ID · ee1e32b5-fc68-4124-9377-7d48f41e5cab
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1190842
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of USV Private Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2019 | Not classified | Office of Inspections and Investigations | |
| August 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1106992 - 2019-09-17
- FDA Inspection 1020024 - 2017-08-02
- FDA Inspection 972077 - 2016-06-10
- FDA Inspection 927397 - 2015-03-27
- FDA Inspection 850631 - 2013-09-06
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