Company
United StatesGenesee BioMedical, Inc., Denver, CO – FDA Inspections
Inspection records and compliance data for Genesee BioMedical, Inc. in Denver, Colorado. 2 FDA inspections on record, 1 Form 483, last inspected February 09, 2018.
Company Profile
This profile covers Genesee BioMedical, Inc. based in Denver, Colorado, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 25, 2011. Last inspected February 9, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate process validation1 inspection
- Report of risk to health1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 9, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1040396 |
| January 25, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 707252 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Genesee BioMedical, Inc.
FEI Number
1000517719
Address
700 W Mississippi Ave Unit D5, Denver, Colorado 80223, United States
Country
United States
ID: c321d66d-1b00-4e30-9cdf-ddee6a6ec502