FDA Inspection
American Catheter CorpAmerican Catheter Corp – FDA Inspection, Jun 17, 2009
Record Details
This FDA Inspection record concerns American Catheter Corp, with an inspection on June 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- American Catheter Corp
- Inspection Date
- June 17, 2009
- Product Type
- Devices
View Company Profile
ID · f6854a9d-4fc5-483a-877d-16440654606b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 590894
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(a)General
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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 |
| April 5, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 21, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for American Catheter Corp
- FDA Inspection 956482 - 2016-01-28
- FDA Inspection 718489 - 2011-04-05
- FDA Inspection 694703 - 2010-10-21
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.