FDA Inspection
Hetero Labs Ltd. Unit VIHetero Labs Ltd. Unit VI – FDA Inspection, Sep 21, 2023
Record Details
This FDA Inspection record concerns Hetero Labs Ltd. Unit VI, with an inspection on September 21, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4d20198b-8e22-4196-b631-b4835f9009f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218220
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Hetero Labs Ltd. Unit VI
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hetero Labs Ltd. Unit VI
- FDA Inspection 999209 - 2016-11-15
- FDA Inspection 833134 - 2013-05-23
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