FDA Inspection
Converting Biophile Laboratories, Inc.Converting Biophile Laboratories, Inc. – FDA Inspection, Aug 2, 2011
Record Details
This FDA Inspection record concerns Converting Biophile Laboratories, Inc., with an inspection on August 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 2, 2011
- Product Type
- Devices
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ID · a3aaa86f-46b8-4337-914b-a645fc7d05fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738440
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 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 |
|---|---|---|---|
| April 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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