FDA Inspection
GNJ Ent IncGNJ Ent Inc – FDA Inspection, Oct 27, 2017
Record Details
This FDA Inspection record concerns GNJ Ent Inc, with an inspection on October 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 17260f0b-3a61-4e1a-9e77-edec4295f79e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030320
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GNJ Ent Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2011 | 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.