FDA Inspection
Converting Biophile Laboratories, Inc.Converting Biophile Laboratories, Inc. – FDA Inspection, Apr 3, 2012
Record Details
This FDA Inspection record concerns Converting Biophile Laboratories, Inc., with an inspection on April 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 3, 2012
- Product Type
- Devices
View Company Profile
ID · 58a805a4-1a88-441f-961b-97a49ade4ca8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775719
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Converting Biophile Laboratories, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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