FDA Inspection
Hetero USA IncHetero USA Inc – FDA Inspection, Mar 17, 2017
Record Details
This FDA Inspection record concerns Hetero USA Inc, with an inspection on March 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4a8ce964-d2f9-4260-b378-f5a95d2e89f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006668
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)[NDA prod] Fail to submit report in apprvd electronic format
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Other FDA inspections of Hetero USA Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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