Company
United StatesAmerican Catheter Corp, Jupiter, FL – FDA Inspections
Inspection records and compliance data for American Catheter Corp in Jupiter, Florida. 4 FDA inspections on record (1 OAI), last inspected January 28, 2016.
Company Profile
This profile covers American Catheter Corp based in Jupiter, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 17, 2009. Last inspected January 28, 2016.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- General1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 28, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 956482 |
| April 5, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 718489 |
| October 21, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 694703 |
| June 17, 2009 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 590894 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
American Catheter Corp
FEI Number
1000151187
Address
357 Cypress Dr Ste 9, Jupiter, Florida 33469, United States
Country
United States
ID: 44aae9bb-6b8a-45e0-a148-7a9a1febe047