FDA Inspection 579202 — Allograft Innovations, LLC
The FDA completed an inspection of Allograft Innovations, LLC on May 6, 2009 in Gainesville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12385 | 21 CFR 1271.150(c)(2) | Responsibility for review before distribution |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12458 | 21 CFR 1271.320(b) | Designated complaint file |