FDA Inspection
Coopervision Manufacturing, LtdCoopervision Manufacturing, Ltd – FDA Inspection, Jan 10, 2019
Record Details
This FDA Inspection record concerns Coopervision Manufacturing, Ltd, with an inspection on January 10, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- January 10, 2019
- Product Type
- Medical Devices & Rad Health
- Person
- Seema S. Singh (Issuing Officer)
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ID · 74b2a6e8-c5ca-4dc2-bb03-ef124d9bf9b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076150
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Documentation
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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 19, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 5, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Coopervision Manufacturing, Ltd
- FDA Inspection 1079354 - 2019-01-17
- FDA Inspection 1006523 - 2017-01-19
- FDA Inspection 859895 - 2013-12-05
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