FDA Inspection
Y&G Group, LLC.Y&G Group, LLC. – FDA Inspection, Apr 14, 2015
Record Details
This FDA Inspection record concerns Y&G Group, LLC., with an inspection on April 14, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Y&G Group, LLC.
- Inspection Date
- April 14, 2015
- Product Type
- Devices
View Company Profile
ID · 51b0c3c5-301e-4ea6-baac-a978710ed55f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 920419
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.