FDA Inspection 789181 — RTI Surgical, Inc.
The FDA completed an inspection of RTI Surgical, Inc. on July 11, 2012 in Alachua, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 11, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Alachua, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |