FDA Inspection
GNJ Ent IncGNJ Ent Inc – FDA Inspection, Jul 22, 2011
Record Details
This FDA Inspection record concerns GNJ Ent Inc, with an inspection on July 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GNJ Ent Inc
- Inspection Date
- July 22, 2011
- Product Type
- Devices
View Company Profile
ID · 9a4c4233-2e8f-415b-aea7-61f78657db46
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737984
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GNJ Ent Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GNJ Ent Inc
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.