FDA Inspection 1316812 — Theo Manufacturing BV
The FDA completed an inspection of Theo Manufacturing BV on May 13, 2026 in Maastricht. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maastricht (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 23068 | ISO 13485:2016 Clause 6.1(b) | Resources for meeting regulatory and customer requirements not provided |
| 23083 | ISO 13485:2016 Clause 6.4.2 | Arrangements for control of contaminated product not planned and documented |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |