FDA Inspection 966729 — ACell, Inc
The FDA completed an inspection of ACell, Inc on March 8, 2016 in Columbia, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 8, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Columbia, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |