FDA Inspection 718489 — American Catheter Corp
The FDA completed an inspection of American Catheter Corp on April 5, 2011 in Jupiter, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 5, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Jupiter, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |