FDA Inspection
Wieland Designs IncWieland Designs Inc – FDA Inspection, Feb 24, 2017
Record Details
This FDA Inspection record concerns Wieland Designs Inc, with an inspection on February 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 01d9587f-59ce-4d70-bc60-daafb17076f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003155
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 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(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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