FDA Inspection
Theo Manufacturing BVTheo Manufacturing BV – FDA Inspection, May 22, 2019
Record Details
This FDA Inspection record concerns Theo Manufacturing BV, with an inspection on May 22, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 86fa59d2-4799-45a7-9f74-b4399f7c8aa9
Inspection Facts
- Inspection number
- 1091098
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Theo Manufacturing BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| November 9, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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