FDA Inspection 1079030 — Memtec Incorporated
The FDA completed an inspection of Memtec Incorporated on February 4, 2019 in Salem, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |