FDA Inspection 1217029 — ZOT ENGINEERING LTD
The FDA completed an inspection of ZOT ENGINEERING LTD on Sep 7, 2023 in Musselburgh. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 7, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Musselburgh (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |