FDA Inspection
Unichem Laboratories Ltd.Unichem Laboratories Ltd. – FDA Inspection, Aug 23, 2019
Record Details
This FDA Inspection record concerns Unichem Laboratories Ltd., with an inspection on August 23, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 36959a18-e9df-4243-b454-13e7ffdc525e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102985
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
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 |
| 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 |
| March 27, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Unichem Laboratories Ltd.
- FDA Inspection 1230023 - 2024-02-13
- FDA Inspection 1087477 - 2019-03-08
- FDA Inspection 1053321 - 2018-04-20
- FDA Inspection 1008000 - 2017-03-03
- FDA Inspection 922881 - 2015-03-27
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