FDA Inspection
Pacific Surgical Distribution, Inc.Pacific Surgical Distribution, Inc. – FDA Inspection, Sep 24, 2009
Record Details
This FDA Inspection record concerns Pacific Surgical Distribution, Inc., with an inspection on September 24, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 24, 2009
- Product Type
- Biologics
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ID · 5b9c50aa-f710-4127-8f89-c5da4200af68
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613666
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.270(c)Back-up of electronic records
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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