FDA Inspection
Pliva, Inc.Pliva, Inc. – FDA Inspection, May 5, 2009
Record Details
This FDA Inspection record concerns Pliva, Inc., with an inspection on May 5, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pliva, Inc.
- Inspection Date
- May 5, 2009
- Product Type
- Drugs
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ID · 3e71cc0c-8ecc-4c15-bbbc-8bf70aef8696
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 584766
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Pliva, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pliva, Inc.
- FDA Inspection 627383 - 2009-11-12
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