FDA Inspection 1098244 — CooperSurgical, Inc.
The FDA completed an inspection of CooperSurgical, Inc. on August 1, 2019 in North Tonawanda, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 1, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Tonawanda, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |