Company
United StatesBiochem Laboratories, Inc., Lyndhurst, NJ – FDA Inspections
Inspection records and compliance data for Biochem Laboratories, Inc. in Lyndhurst, New Jersey. 6 FDA inspections on record (1 OAI), 2 Form 483s, last inspected July 24, 2025.
Company Profile
This profile covers Biochem Laboratories, Inc. based in Lyndhurst, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 5
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected July 9, 2010. Last inspected July 24, 2025.
Most cited issue areas
- Scientifically sound laboratory controls3 inspections
- Calculations performed are in the records2 inspections
- Calibration - at intervals, written program, remedial action2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 24, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1276819 |
| March 26, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1083917 |
| June 10, 2014 | VAI | Human Drugs · Drug Quality Assurance | 882449 |
| May 14, 2012 | VAI | Human Drugs · Drug Quality Assurance | 779784 |
| June 15, 2011 | OAI | Human Drugs · Drug Quality Assurance | 730683 |
| July 9, 2010 | VAI | Human Drugs · Drug Quality Assurance | 671029 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biochem Laboratories, Inc.
FEI Number
3005094136
Address
56 Park Ave, Lyndhurst, New Jersey 07071, United States
Country
United States
ID: 79d2c426-5ad0-4d7f-998a-c53ba9a651a1