FDA Inspection
Watson Pharma Private LimitedWatson Pharma Private Limited – FDA Inspection, Oct 7, 2016
Record Details
This FDA Inspection record concerns Watson Pharma Private Limited, with an inspection on October 7, 2016, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 4057648c-a846-4cee-b4b6-c5f8dc69d542
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996117
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.194(e)Stability testing records not included
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Watson Pharma Private Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2025 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| January 23, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Watson Pharma Private Limited
- FDA Inspection 1270737 - 2025-05-20
- FDA Inspection 1115640 - 2020-01-23
- FDA Inspection 1055330 - 2018-04-26
- FDA Inspection 938682 - 2015-07-21
- FDA Inspection 873929 - 2014-03-14
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