FDA Inspection
Unichem Laboratories Ltd.Unichem Laboratories Ltd. – FDA Inspection, Mar 27, 2015
Record Details
This FDA Inspection record concerns Unichem Laboratories Ltd., with an inspection on March 27, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Unichem Laboratories Ltd.
- Inspection Date
- March 27, 2015
- Product Type
- Drugs
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ID · 61e0c092-51ff-434c-9f94-1a5983351232
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 922881
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Unichem Laboratories Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 3, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Unichem Laboratories Ltd.
- FDA Inspection 1230023 - 2024-02-13
- FDA Inspection 1102985 - 2019-08-23
- FDA Inspection 1087477 - 2019-03-08
- FDA Inspection 1053321 - 2018-04-20
- FDA Inspection 1008000 - 2017-03-03
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