FDA Inspection
Hetero Labs Limited (Unit V)Hetero Labs Limited (Unit V) – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns Hetero Labs Limited (Unit V), with an inspection on April 26, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 34274ef5-869d-4bbb-8f21-12d23eca7063
Inspection Facts
- Inspection number
- 1087785
- 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 211.188(b)(10)Documentation of Sampling Performed
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Other FDA inspections of Hetero Labs Limited (Unit V)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| August 12, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 1, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 24, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hetero Labs Limited (Unit V)
- FDA Inspection 1329640 - 2026-08-07
- FDA Inspection 1178448 - 2022-08-12
- FDA Inspection 995278 - 2016-12-16
- FDA Inspection 928952 - 2015-05-01
- FDA Inspection 837768 - 2013-05-24
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