LifeCell CorporationJune 14, 2019

FDA 483 - LifeCell Corporation - June 14, 2019

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore LifeCell Corporation

Record Details

The FDA inspected LifeCell Corporation, a subsidiary of Allergan PLC, in Branchburg, NJ, from May 14 to June 14, 2019. The inspection revealed significant deficiencies in the firm's quality system, including inadequate process validation for cleaning and insufficient corrective and preventive action procedures. Additionally, failures in document control for design changes and an inadequate management review process were noted.

Company: LifeCell Corporation
Inspection Date: June 14, 2019
Product Type: Other
Office: New Jersey District Office
Person: Frank J. Marciniak

Open in Dashboard

ID · 5ec2bea2-1d82-45e5-8a60-93a44a7009c2