FDA Inspection
Hetero Labs Limited (Unit V)Hetero Labs Limited (Unit V) – FDA Inspection, Aug 7, 2026
Record Details
This FDA Inspection record concerns Hetero Labs Limited (Unit V), with an inspection on August 7, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 109b113a-43f0-40ad-be4f-fd879ea23eee
Inspection Facts
- Inspection number
- 1329640
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Component written specification
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Other FDA inspections of Hetero Labs Limited (Unit V)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2019 | Not classified | Office of Inspections and Investigations | 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 1178448 - 2022-08-12
- FDA Inspection 1087785 - 2019-04-26
- FDA Inspection 995278 - 2016-12-16
- FDA Inspection 928952 - 2015-05-01
- FDA Inspection 837768 - 2013-05-24
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