FDA Inspection 1025149 — Ethicon, Inc.
The FDA completed an inspection of Ethicon, Inc. on September 14, 2017 in Cornelia, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cornelia, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 537 | 21 CFR 820.70(a) | Production processes |