FDA Inspection
Evotronics IncEvotronics Inc – FDA Inspection, Oct 23, 2017
Record Details
This FDA Inspection record concerns Evotronics Inc, with an inspection on October 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f09db441-9cc0-44ff-816e-78567f3433a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030175
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
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