FDA Inspection
Anhui Greenland Biotech Co., Ltd.Anhui Greenland Biotech Co., Ltd. – FDA Inspection, May 9, 2019
Record Details
This FDA Inspection record concerns Anhui Greenland Biotech Co., Ltd., with an inspection on May 9, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d29623ae-7b11-405d-a6ad-ad85c8b23e20
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1092638
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.184(f)DHR - UDI not included
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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