FDA Inspection
Tokyo Boeki Medisys, Inc.Tokyo Boeki Medisys, Inc. – FDA Inspection, Mar 24, 2017
Record Details
This FDA Inspection record concerns Tokyo Boeki Medisys, Inc., with an inspection on March 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ccbdde21-c773-4e94-9ace-61a23b0d9b7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009378
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Tokyo Boeki Medisys, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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