FDA Inspection
Hetero Labs Limited - Unit IIIHetero Labs Limited - Unit III – FDA Inspection, Oct 26, 2016
Record Details
This FDA Inspection record concerns Hetero Labs Limited - Unit III, with an inspection on October 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6950965a-2a58-407d-92cd-3aab7a4e5d09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993030
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(4)Complete Test Data
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Other FDA inspections of Hetero Labs Limited - Unit III
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 7, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2018 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| March 23, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 31, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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