FDA Inspection
HENGRUI MEDICAL PACKAGING CO., LTDHENGRUI MEDICAL PACKAGING CO., LTD – FDA Inspection, Oct 27, 2016
Record Details
This FDA Inspection record concerns HENGRUI MEDICAL PACKAGING CO., LTD, with an inspection on October 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 06daafc9-5645-4aba-a050-2126bda07d07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991784
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.86Acceptance status
- 21 CFR 820.72(b)Remedial action
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