FDA Inspection
Carolina Surgical Solutions, LLCCarolina Surgical Solutions, LLC – FDA Inspection, May 20, 2014
Record Details
This FDA Inspection record concerns Carolina Surgical Solutions, LLC, with an inspection on May 20, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 20, 2014
- Product Type
- Biologics
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ID · c61998ba-506a-4699-81a5-8be9687c1e7c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 878481
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.260(e)Temperature limits
- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.320(a)Procedures re complaints
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