FDA Inspection
Trutek CorpTrutek Corp – FDA Inspection, Jan 16, 2026
Record Details
This FDA Inspection record concerns Trutek Corp, with an inspection on January 16, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · f1e58e89-1dd3-4547-a263-359642c518ce
Inspection Facts
- Inspection number
- 1298746
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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Other FDA inspections of Trutek Corp
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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