FDA Inspection
Ameritek USA, Inc.Ameritek USA, Inc. – FDA Inspection, Sep 8, 2010
Record Details
This FDA Inspection record concerns Ameritek USA, Inc., with an inspection on September 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ameritek USA, Inc.
- Inspection Date
- September 8, 2010
- Product Type
- Devices
View Company Profile
ID · 121463c7-fdf1-4af3-b3be-e43eb75fe122
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682875
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ameritek USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 12, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 17, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ameritek USA, Inc.
- FDA Inspection 1243511 - 2024-07-10
- FDA Inspection 918166 - 2015-03-12
- FDA Inspection 799088 - 2012-09-17
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.