FDA Inspection
Sontec Instruments, IncSontec Instruments, Inc – FDA Inspection, Oct 21, 2016
Record Details
This FDA Inspection record concerns Sontec Instruments, Inc, with an inspection on October 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 14a0f6d0-8957-4626-b794-9110938aac16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991205
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.30(g)Design validation - documentation
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