FDA Inspection 1313752 — MAST GROUP LTD
The FDA completed an inspection of MAST GROUP LTD on Mar 26, 2026 in Bootle. 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
- Mar 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bootle (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 23080 | ISO 13485:2016 Clause 6.4.1 | Work environment requirements and procedures not documented |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |