FDA Inspection 745826 — Advanced Medical Systems & Solutions
The FDA completed an inspection of Advanced Medical Systems & Solutions on Sep 27, 2011 in Bristol, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 27, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Bristol, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |