FDA Inspection 551933 — Modern Surgical Inc
The FDA completed an inspection of Modern Surgical Inc on Dec 11, 2008 in Gulf Shores, AL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 11, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Gulf Shores, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |