FDA Inspection 600146 — CooperSurgical, Inc.
The FDA completed an inspection of CooperSurgical, Inc. on Jul 19, 2009 in Trumbull, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 19, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Trumbull, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |