FDA Inspection
Buffalo Dental Manufacturing Co., Inc.Buffalo Dental Manufacturing Co., Inc. – FDA Inspection, Dec 22, 2015
Record Details
This FDA Inspection record concerns Buffalo Dental Manufacturing Co., Inc., with an inspection on December 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 22, 2015
- Product Type
- Devices
View Company Profile
ID · 4129bab8-2196-4e57-b21b-ff4e4f846d40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953329
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.65Traceability Lack of or inadequate {see also 820.120(e)}
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.184DHR content
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Other FDA inspections of Buffalo Dental Manufacturing Co., Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 2, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 10, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Buffalo Dental Manufacturing Co., Inc.
- FDA Inspection 1092253 - 2019-05-20
- FDA Inspection 872967 - 2014-04-02
- FDA Inspection 776526 - 2012-04-10
- FDA Inspection 618007 - 2009-09-18
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