FDA Inspection
Phoenix Divina Products LlcPhoenix Divina Products Llc – FDA Inspection, Apr 7, 2010
Record Details
This FDA Inspection record concerns Phoenix Divina Products Llc, with an inspection on April 7, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Phoenix Divina Products Llc
- Inspection Date
- April 7, 2010
- Product Type
- Drugs
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ID · 48dad3dc-2369-4b75-9a71-7808888cc09c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 656096
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Phoenix Divina Products Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2009 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Phoenix Divina Products Llc
- FDA Inspection 579561 - 2009-05-01
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