FDA Inspection 770318 — Ethicon, Inc.
The FDA completed an inspection of Ethicon, Inc. on February 27, 2012 in Cornelia, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 27, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Cornelia, GA (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |