FDA Inspection
American Catheter CorpAmerican Catheter Corp – FDA Inspection, Apr 5, 2011
Record Details
This FDA Inspection record concerns American Catheter Corp, with an inspection on April 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- American Catheter Corp
- Inspection Date
- April 5, 2011
- Product Type
- Devices
View Company Profile
ID · 69dd38ba-a548-4eb8-b800-b9f90463af2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 718489
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of American Catheter Corp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 21, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 17, 2009 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for American Catheter Corp
- FDA Inspection 956482 - 2016-01-28
- FDA Inspection 694703 - 2010-10-21
- FDA Inspection 590894 - 2009-06-17
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.