FDA Inspection
Genesee BioMedical, Inc.Genesee BioMedical, Inc. – FDA Inspection, Feb 9, 2018
Record Details
This FDA Inspection record concerns Genesee BioMedical, Inc., with an inspection on February 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · bf06b93f-d2f9-40ee-b409-d764d34a4be9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040396
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genesee BioMedical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Genesee BioMedical, Inc.
- FDA Inspection 707252 - 2011-01-25
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.