Company
United StatesBiogenesis, Inc, Paterson, NJ – FDA Inspections
Inspection records and compliance data for Biogenesis, Inc in Paterson, New Jersey. 5 FDA inspections on record, 1 Form 483, last inspected February 27, 2025.
Company Profile
This profile covers Biogenesis, Inc based in Paterson, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 5, 2010. Last inspected February 27, 2025.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Adequate number of batches on stability1 inspection
- Annual visual exams of drug products1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 27, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1260213 |
| January 17, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1116511 |
| November 18, 2014 | VAI | Human Drugs · Drug Quality Assurance | 904579 |
| February 2, 2012 | VAI | Human Drugs · Drug Quality Assurance | 765724 |
| August 5, 2010 | VAI | Human Drugs · Drug Quality Assurance | 669967 |
FDA documents
Form 483s (1)
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Company Information
Name
Biogenesis, Inc
FEI Number
3004933570
Address
444 Marshall St, Paterson, New Jersey 07503, United States
Country
United States
ID: 847a28b3-ca74-493b-a09f-eedbdfa0c5fc