FDA Inspection 801430 — Allograft Innovations, LLC
The FDA completed an inspection of Allograft Innovations, LLC on October 3, 2012 in Gainesville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 3, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12321 | 21 CFR 1271.160(b)(3) | Problem description, disposition, date et. al. |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12426 | 21 CFR 1271.265(c)(2) | Improperly released for distribution |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |