FDA Inspection 878481 — Carolina Surgical Solutions, LLC
The FDA completed an inspection of Carolina Surgical Solutions, LLC on May 20, 2014 in Florence, SC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 20, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Florence, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12415 | 21 CFR 1271.260(e) | Temperature limits |
| 12421 | 21 CFR 1271.265(a) | Acceptance criteria designed to prevent CD |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |