FDA Inspection
PHRK Intervention IncPHRK Intervention Inc – FDA Inspection, Sep 5, 2014
Record Details
This FDA Inspection record concerns PHRK Intervention Inc, with an inspection on September 5, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- PHRK Intervention Inc
- Inspection Date
- September 5, 2014
- Product Type
- Biologics
View Company Profile
ID · 11306c94-831f-48e4-8389-8447eb5a2d72
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 895498
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of PHRK Intervention Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 21, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for PHRK Intervention Inc
- FDA Inspection 1072665 - 2018-10-18
- FDA Inspection 953341 - 2015-10-21
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