FDA Inspection
Unichem Laboratories Ltd.Unichem Laboratories Ltd. – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Unichem Laboratories Ltd., with an inspection on March 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 020d0680-36cf-4306-95cd-467bb82ec0a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008000
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 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 1102985 - 2019-08-23
- FDA Inspection 1087477 - 2019-03-08
- FDA Inspection 1053321 - 2018-04-20
- FDA Inspection 922881 - 2015-03-27
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