FDA Inspection 924375 — Ethicon, Inc.
The FDA completed an inspection of Ethicon, Inc. on April 24, 2015 in Cornelia, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Cornelia, GA (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |