FDA Inspection
LUPIN LIMITEDLUPIN LIMITED – FDA Inspection, Jan 18, 2019
Record Details
This FDA Inspection record concerns LUPIN LIMITED, with an inspection on January 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1c3a2003-87d8-445f-811c-d6e5ba93e14b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076889
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(j)Failure to maintain records
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Other FDA inspections of LUPIN LIMITED
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for LUPIN LIMITED
- FDA Inspection 1217650 - 2023-03-24
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