FDA Inspection
Hetero Labs Limited - Unit IIIHetero Labs Limited - Unit III – FDA Inspection, Oct 26, 2018
Record Details
This FDA Inspection record concerns Hetero Labs Limited - Unit III, with an inspection on October 26, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 67944bc2-338c-4533-a2e7-85603555e425
Inspection Facts
- Inspection number
- 1071009
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
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Other FDA inspections of Hetero Labs Limited - Unit III
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|---|---|---|---|
| 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 |
| March 23, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2016 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| July 31, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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