FDA Inspection 1102645 — Polymerex Medical Corp
The FDA completed an inspection of Polymerex Medical Corp on September 23, 2019 in San Diego, CA. 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
- September 23, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |