FDA Inspection
Huaiyin Medical Instruments Co., Ltd.Huaiyin Medical Instruments Co., Ltd. – FDA Inspection, Apr 2, 2009
Record Details
This FDA Inspection record concerns Huaiyin Medical Instruments Co., Ltd., with an inspection on April 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 2, 2009
- Product Type
- Devices
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ID · ccfd5d4b-d99f-44a3-b2f6-4a92ec23aa2c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 581723
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.250(a)Invalid technique
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.198(e)(4)Complainant data
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