FDA Inspection 1108578 — Pathen Medical LLC
The FDA completed an inspection of Pathen Medical LLC on November 1, 2019 in Sanford, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 1, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |