FDA Inspection
Troy Biologicals, Inc.Troy Biologicals, Inc. – FDA Inspection, Dec 29, 2010
Record Details
This FDA Inspection record concerns Troy Biologicals, Inc., with an inspection on December 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Troy Biologicals, Inc.
- Inspection Date
- December 29, 2010
- Product Type
- Devices
View Company Profile
ID · e9152275-5ffc-426f-99c4-89a7c1c89264
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702853
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 820.50(b)Supplier notification of changes
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
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 |
| March 30, 2009 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Troy Biologicals, Inc.
- FDA Inspection 742282 - 2011-08-17
- FDA Inspection 574956 - 2009-03-30
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.