FDA Inspection
B.Y. Medimor LtdB.Y. Medimor Ltd – FDA Inspection, Feb 25, 2016
Record Details
This FDA Inspection record concerns B.Y. Medimor Ltd, with an inspection on February 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- B.Y. Medimor Ltd
- Inspection Date
- February 25, 2016
- Product Type
- Devices
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ID · a5582789-e459-434a-8342-78ebca190253
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986552
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of B.Y. Medimor Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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