FDA Inspection
Coopervision Manufacturing, LtdCoopervision Manufacturing, Ltd – FDA Inspection, Dec 5, 2013
Record Details
This FDA Inspection record concerns Coopervision Manufacturing, Ltd, with an inspection on December 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 5, 2013
- Product Type
- Devices
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ID · b598e19a-86ae-4684-bf96-96ab3631ef90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859895
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Coopervision Manufacturing, Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 10, 2019 | VAI | Office of Inspections and Investigations | Project Evaluation: Devices |
| January 19, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Coopervision Manufacturing, Ltd
- FDA Inspection 1079354 - 2019-01-17
- FDA Inspection 1076150 - 2019-01-10
- FDA Inspection 1006523 - 2017-01-19
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