FDA Inspection
Hetero Labs Ltd. - Unit IXHetero Labs Ltd. - Unit IX – FDA Inspection, Aug 18, 2017
Record Details
This FDA Inspection record concerns Hetero Labs Ltd. - Unit IX, with an inspection on August 18, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Bijoy Panicker
- Ivy E. Sweeney (Issuing Officer)
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ID · a432d02c-69aa-4d9f-a360-63a3e29d6d14
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024034
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Hetero Labs Ltd. - Unit IX
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | Not classified | Office of Inspections and Investigations | |
| November 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 14, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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