FDA Inspection
BIOXIN MEDICAL CO., LTDBIOXIN MEDICAL CO., LTD – FDA Inspection, Apr 4, 2019
Record Details
This FDA Inspection record concerns BIOXIN MEDICAL CO., LTD, with an inspection on April 4, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 065ad353-b9f3-44ea-b898-c5eb764de967
Inspection Facts
- Inspection number
- 1086439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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