Company
United StatesLifeCell Corporation, Branchburg, NJ – FDA Inspections
Inspection records and compliance data for LifeCell Corporation in Branchburg, New Jersey. 13 FDA inspections on record (1 OAI), 4 Form 483s, 1 warning letter, last inspected September 21, 2026.
Company Profile
This profile covers LifeCell Corporation based in Branchburg, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 13
- OAI
- 1
- VAI
- 2
- NAI
- 8
- Unclassified
- 2
- Form 483s
- 4
- Warning letters
- 1
First inspected November 19, 2009. Last inspected September 21, 2026.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate process validation2 inspections
- Procedures not adequately established or maintained2 inspections
FDA inspections (13)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 21, 2026 | Not classified | Biologics · Human Cellular, Tissue, and Gene Therapies | 1329332 |
| May 21, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1230349 |
| February 20, 2020 | NAI | Biologics · Blood and Blood Products | 1120984 |
| June 14, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1095091 |
| January 10, 2019 | Not classified | Medical Devices & Rad Health | 1089602 |
| September 27, 2017 | NAI | Biologics · Blood and Blood Products | 1028651 |
| August 25, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1023275 |
| June 21, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 980020 |
| May 14, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 928848 |
| September 16, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 850526 |
| August 15, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 742158 |
| November 12, 2010 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 698825 |
| November 19, 2009 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 629416 |
FDA documents
Form 483s (2)
Warning Letters (1)
EIRs (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
LifeCell Corporation
FEI Number
1000306051
Address
4 Millennium Way, Branchburg, New Jersey 08876, United States
Country
United States
ID: befaec51-e133-4222-ad7e-0cf8e59f5d23