FDA Inspection
Joson-Care Enterprise Co., Ltd.Joson-Care Enterprise Co., Ltd. – FDA Inspection, Sep 8, 2016
Record Details
This FDA Inspection record concerns Joson-Care Enterprise Co., Ltd., with an inspection on September 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 8, 2016
- Product Type
- Devices
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ID · 79d72cd6-c2bd-4d51-8818-d5e295515c71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994031
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 803.17Lack of Written MDR Procedures
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