FDA Inspection
Microjenics, Inc.Microjenics, Inc. – FDA Inspection, Aug 11, 2010
Record Details
This FDA Inspection record concerns Microjenics, Inc., with an inspection on August 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Microjenics, Inc.
- Inspection Date
- August 11, 2010
- Product Type
- Devices
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ID · 515f7181-8660-4969-876a-955555065c5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 679188
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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