FDA Inspection
Fu Shun Hsing Technology Co. Ltd.Fu Shun Hsing Technology Co. Ltd. – FDA Inspection, Aug 29, 2019
Record Details
This FDA Inspection record concerns Fu Shun Hsing Technology Co. Ltd., with an inspection on August 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cabc98de-ecaa-4908-a836-5fe3ab95727b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102390
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.30(j)Design history file
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