FDA Inspection
NDX ThayerNDX Thayer – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns NDX Thayer, with an inspection on February 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fa2fdb5e-9cbf-49ab-a3c4-ac12a27ef535
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040691
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audits - defined intervals
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