FDA Inspection
Trutek CorpTrutek Corp – FDA Inspection, Jan 18, 2024
Record Details
This FDA Inspection record concerns Trutek Corp, with an inspection on January 18, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d5de688d-da62-47fe-9365-5392daa63f81
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1227244
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
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Other FDA inspections of Trutek Corp
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2026 | Not classified | New Jersey District Office | Compliance: Medical Devices |
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