FDA Inspection
Womed SasWomed Sas – FDA Inspection, Nov 28, 2024
Record Details
This FDA Inspection record concerns Womed Sas, with an inspection on November 28, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e8e83936-48b7-4e3e-8297-0909d480faf8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1255289
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Womed Sas
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2024 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Womed Sas
- FDA Inspection 1253885 - 2024-10-17
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