FDA Inspection
CooperSurgical, Inc.CooperSurgical, Inc. – FDA Inspection, Jul 19, 2009
Record Details
This FDA Inspection record concerns CooperSurgical, Inc., with an inspection on July 19, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CooperSurgical, Inc.
- Inspection Date
- July 19, 2009
- Product Type
- Drugs
View Company Profile
ID · 513b32e7-8d4e-420b-b33b-27b72a33d205
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 600146
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.103Yield calculations not verified by 2nd person
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Other FDA inspections of CooperSurgical, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 15, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CooperSurgical, Inc.
- FDA Inspection 1236656 - 2024-05-21
- FDA Inspection 1209056 - 2023-05-16
- FDA Inspection 1146202 - 2021-07-15
- FDA Inspection 1042445 - 2017-12-07
- FDA Inspection 1007880 - 2017-03-28
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