FDA Inspection
Opgen, Inc.Opgen, Inc. – FDA Inspection, Nov 19, 2015
Record Details
This FDA Inspection record concerns Opgen, Inc., with an inspection on November 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Opgen, Inc.
- Inspection Date
- November 19, 2015
- Product Type
- Devices
View Company Profile
ID · 63a1522e-54f3-4065-8f32-99230ac3b6fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954609
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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