FDA Inspection
Femcare, Ltd.Femcare, Ltd. – FDA Inspection, Jul 25, 2019
Record Details
This FDA Inspection record concerns Femcare, Ltd., with an inspection on July 25, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · cfbfc41c-7020-4da3-acc4-3d0b0971470f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097440
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Femcare, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Femcare, Ltd.
- FDA Inspection 585862 - 2009-05-21
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