FDA Inspection
Thermo Products, LLCThermo Products, LLC – FDA Inspection, Jul 30, 2009
Record Details
This FDA Inspection record concerns Thermo Products, LLC, with an inspection on July 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thermo Products, LLC
- Inspection Date
- July 30, 2009
- Product Type
- Devices
View Company Profile
ID · 5dd0d2b2-d37f-41d3-a3e8-2d556082e3c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596990
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
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.