FDA Inspection 736370 — ALLORX LLC
The FDA completed an inspection of ALLORX LLC on July 22, 2011 in Ocean Springs, MS. 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
- July 22, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Ocean Springs, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12340 | 21 CFR 1271.180(d) | Adopted from another organization |
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12446 | 21 CFR 1271.290(a) | HCT/Ps not tracked |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |