FDA Inspection
Pacific Denshi Co., Ltd.Pacific Denshi Co., Ltd. – FDA Inspection, Aug 9, 2012
Record Details
This FDA Inspection record concerns Pacific Denshi Co., Ltd., with an inspection on August 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pacific Denshi Co., Ltd.
- Inspection Date
- August 9, 2012
- Product Type
- Devices
View Company Profile
ID · b2a1146b-8926-4fab-bd3d-7892a3d561d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803599
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.198(a)General
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.200(d)(3)Service date
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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