FDA Inspection 1309182 — Assembly Contracts Ltd
The FDA completed an inspection of Assembly Contracts Ltd on March 25, 2026 in Manchester. 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
- March 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Manchester (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |