FDA Inspection 975148 — Amniotic Therapies LLC
The FDA completed an inspection of Amniotic Therapies LLC on May 4, 2016 in Farmers Branch, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 4, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Farmers Branch, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12337 | 21 CFR 1271.180(a) | Design adequate to bar spread of CD's |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |
| 12469 | 21 CFR 1271.350(a)(1) | Adverse reaction reporting to FDA |