FDA Inspection
Theo Manufacturing BVTheo Manufacturing BV – FDA Inspection, May 13, 2026
Record Details
This FDA Inspection record concerns Theo Manufacturing BV, with an inspection on May 13, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 5e123b3b-2ea2-4239-98f0-d8291a5a7017
Inspection Facts
- Inspection number
- 1316812
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 6.1(b)Resources for meeting regulatory and customer requirements not provided
- ISO 13485:2016 Clause 6.4.2Arrangements for control of contaminated product not planned and documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Theo Manufacturing BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 22, 2019 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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