FDA Inspection 782535 — CooperSurgical, Inc.
The FDA completed an inspection of CooperSurgical, Inc. on May 23, 2012 in North Tonawanda, 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Tonawanda, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |