FDA Inspection 1047905 — CooperVision, Inc.
The FDA completed an inspection of CooperVision, Inc. on April 11, 2018 in West Henrietta, NY. 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 11, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Henrietta, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3230 | 21 CFR 820.70(i) | Validation of changes to automated process software |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |