FDA Inspection
SpineSmith Partners, LPSpineSmith Partners, LP – FDA Inspection, Oct 15, 2009
Record Details
This FDA Inspection record concerns SpineSmith Partners, LP, with an inspection on October 15, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- SpineSmith Partners, LP
- Inspection Date
- October 15, 2009
- Product Type
- Biologics
View Company Profile
ID · 33e01532-441c-4c86-967a-882db086f85e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 620292
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(2)Procedures for complaints and other information
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