FDA Intel

LifeCell Corporation

Form 483 issued June 14, 2019 · Branchburg, New Jersey

Inspection
May 14 – Jun 14, 2019
Investigator
Frank J. Marciniak
Observations
4
Pages
3
FEI number
1000306051

In short: On June 14, 2019, FDA issued a Form 483 with 4 observations to LifeCell Corporation in Branchburg, New Jersey (FEI 1000306051) after an inspection that ran May 14 – Jun 14, 2019. The investigator was Frank J. Marciniak. Most observations concern production & process controls and cAPA.

At a glance

Observations span 4 systems, led by production & process controls.

Production & process controls1
CAPA1
Records & documents1
Management controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.75(a)

    A process whose results cannot be fully verified by subsequent inspection and test has not been…

  2. 02
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

  3. 03
    21 CFR 820.40

    Document control procedures have…

  4. 04
    21 CFR 820.20(c)

    Procedures for management review have…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Frank J. Marciniak

7 documents · 2018–2023

Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.

The firm

LifeCell Corporation history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.75(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at LifeCell Corporation?

FDA listed 4 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.

Who inspected LifeCell Corporation?

Frank J. Marciniak is named on this Form 483, for the inspection of May 14 – Jun 14, 2019. Each investigator has a profile showing what they cite most.

When was LifeCell Corporation inspected by FDA?

The inspection ran May 14 – Jun 14, 2019, and the Form 483 is dated June 14, 2019.

How do I get the full Form 483 for LifeCell Corporation?

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