Company
United StatesBio Gen Technologies, Inc, Skaneateles, NY – FDA Inspections
Inspection records and compliance data for Bio Gen Technologies, Inc in Skaneateles, New York. 3 FDA inspections on record, 2 Form 483s, last inspected August 16, 2024.
Company Profile
This profile covers Bio Gen Technologies, Inc based in Skaneateles, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 10, 2018. Last inspected August 16, 2024.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design validation - software validation not performed1 inspection
- Label to bear a unique device identifier1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 16, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1247229 |
| September 16, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1152302 |
| April 10, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1048028 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bio Gen Technologies, Inc
FEI Number
3008140960
Address
2433 Wave Way, Skaneateles, New York 13152, United States
Country
United States
ID: 1d0bbcde-0cdc-4fba-8371-7bc6252f5d1a