FDA Inspection
MedGo LLCMedGo LLC – FDA Inspection, Sep 4, 2014
Record Details
This FDA Inspection record concerns MedGo LLC, with an inspection on September 4, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MedGo LLC
- Inspection Date
- September 4, 2014
- Product Type
- Devices
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ID · f93414db-bf14-4de3-80dd-0600fb457e77
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893683
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.205(a)Master manufacturing record - each batch
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Other FDA inspections of MedGo LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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