LifeCell Corporation
Form 483 issued September 27, 2006 · Somerville, New Jersey
- Inspection
- Sep 11 – Sep 27, 2006
- Investigator
- Helen B. Ricalde
- Observations
- 6
- Pages
- 3
- FEI number
- 1000306051
In short: On September 27, 2006, FDA issued a Form 483 with 6 observations to LifeCell Corporation in Somerville, New Jersey (FEI 1000306051) after an inspection that ran Sep 11 – Sep 27, 2006. The investigator was Helen B. Ricalde. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.55 (what records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?).
At a glance
6 of 6 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.55 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Donors were not screened by a review of relevant medical records for clinical evidence of communicable…
- 02
After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records…
- 03
The quality program has not ensured that appropriate procedures related to core CGTP requirements were…
- 04
The quality program has not ensured the proper training and education of personnel involved…
This inspection in context
Helen B. Ricalde
9 documents · 2003–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmLifeCell Corporation history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 1271.55
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LifeCell Corporation?
FDA listed 6 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.55 (what records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?). The opening words of each observation are shown on this page.
Who inspected LifeCell Corporation?
Helen B. Ricalde is named on this Form 483, for the inspection of Sep 11 – Sep 27, 2006. Each investigator has a profile showing what they cite most.
When was LifeCell Corporation inspected by FDA?
The inspection ran Sep 11 – Sep 27, 2006, and the Form 483 is dated September 27, 2006.
How do I get the full Form 483 for LifeCell Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.