FDA Inspection
Bio Protech, Inc.Bio Protech, Inc. – FDA Inspection, Dec 9, 2010
Record Details
This FDA Inspection record concerns Bio Protech, Inc., with an inspection on December 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bio Protech, Inc.
- Inspection Date
- December 9, 2010
- Product Type
- Devices
View Company Profile
ID · 57b6546f-2b2e-4501-b2e0-b3a80ba4e4b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 704336
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Bio Protech, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| March 23, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bio Protech, Inc.
- FDA Inspection 1318198 - 2026-04-09
- FDA Inspection 977719 - 2016-03-23
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