FDA Inspection
IntroMedic Co., Ltd.IntroMedic Co., Ltd. – FDA Inspection, Jul 6, 2017
Record Details
This FDA Inspection record concerns IntroMedic Co., Ltd., with an inspection on July 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bb2f3608-57cd-46f4-9558-41559b5baa73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019052
- 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 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 806.20(a)Records not kept
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