FDA Inspection
AMD Medicom Inc. (GRANBY PLANT)AMD Medicom Inc. (GRANBY PLANT) – FDA Inspection, Feb 9, 2017
Record Details
This FDA Inspection record concerns AMD Medicom Inc. (GRANBY PLANT), with an inspection on February 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 9ccb46e0-6778-49b1-8fa5-ac6bef4dfa6e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1001543
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AMD Medicom Inc. (GRANBY PLANT)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AMD Medicom Inc. (GRANBY PLANT)
- FDA Inspection 820366 - 2013-02-14
- FDA Inspection 584594 - 2009-05-08
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.