483
LifeCell CorporationLifeCell Corporation – FDA 483, Jun 14, 2019
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.
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