FDA Inspection 1146202 — CooperSurgical, Inc.
The FDA completed an inspection of CooperSurgical, Inc. on July 15, 2021 in Trumbull, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 15, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Trumbull, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3312 | 21 CFR 820.120(d) | Mixups |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |