FDA Inspection
Troy Biologicals, Inc.Troy Biologicals, Inc. – FDA Inspection, Mar 30, 2009
Record Details
This FDA Inspection record concerns Troy Biologicals, Inc., with an inspection on March 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Troy Biologicals, Inc.
- Inspection Date
- March 30, 2009
- Product Type
- Devices
View Company Profile
ID · 997081bf-ae4a-4a27-8dca-b36b27182029
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 574956
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.150(a)Storage procedures to prevent mix-ups
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
Showing 10 of 11 citations.
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Other FDA inspections of Troy Biologicals, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 29, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Troy Biologicals, Inc.
- FDA Inspection 742282 - 2011-08-17
- FDA Inspection 702853 - 2010-12-29
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