LifeCell Corporation
FDA inspection history across 4 sites, 2006 to 2019
- 2
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
- Warning letter
2006: one Form 483; 2008: one warning letter; 2015: one warning letter; 2017: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2006–08One Form 483 and one warning letter, at Somerville, New Jersey.
- 2006The longest 483 on file: 6 observations over 3 pages at Somerville, New Jersey.
- 2015–19One warning letter, one close-out letter and one Form 483, at Bridgewater, New Jersey; Silver Spring, Maryland and Branchburg, New Jersey.
Cited most
Across all LifeCell observations on file
- 21 CFR 1271.55What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?3
- 21 CFR 1271.160Establishment and maintenance of a quality program1
- 21 CFR 1271.170Personnel1
- 21 CFR 1271.75How do I screen a donor?1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete LifeCell file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Somerville, New Jersey
One warning letter and one Form 483 · 2006 to 2008 · 6 observations
Latest: Warning letter, Oct 10, 2008 →Branchburg, New Jersey
One Form 483 · 2019 · 4 observations
Latest: Form 483, Jun 14, 2019 →Silver Spring, Maryland
One close-out letter · 2017
Latest: Close-out, Feb 14, 2017 →Bridgewater, New Jersey
One warning letter · 2015
Latest: Warning letter, Jun 1, 2015 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-14 | 483 Form 483 | Branchburg, New Jersey | 4 | $99 |
| 2017-02-14 | Close-out Close-out letter | Silver Spring, Maryland | — | $99 |
| 2015-06-01 | Warning letter Warning letter | Bridgewater, New Jersey | — | $99 |
| 2008-10-10 | Warning letter Warning letter | Somerville, New Jersey | — | $99 |
| 2006-09-27 | 483 Form 483 | Somerville, New Jersey | 6 | $99 |
Investigators on these documents
FEI number 1000306051 · most recent document Jun 14, 2019
About LifeCell Corporation
How many FDA Form 483s has LifeCell Corporation received?
FDA Intel has 2 Form 483s on file for LifeCell Corporation; the most recent is dated Jun 14, 2019.
When was LifeCell Corporation last inspected by FDA?
The most recent FDA inspection document on file for LifeCell Corporation is a Form 483 dated Jun 14, 2019, for the site in Branchburg, New Jersey.
What did FDA cite at LifeCell Corporation?
The regulations cited most in the observations on file for LifeCell Corporation are 21 CFR 1271.55 (What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?), 3 times; 21 CFR 1271.160 (Establishment and maintenance of a quality program), 1 time; 21 CFR 1271.170 (Personnel), 1 time.
Has LifeCell Corporation received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for LifeCell Corporation; the most recent is dated Jun 1, 2015.