# FDA 483 - LifeCell Corporation - June 14, 2019

Source: https://www.keypedia.com/records/483/lifecell-corporation/5ec2bea2-1d82-45e5-8a60-93a44a7009c2

> FDA 483 for LifeCell Corporation on June 14, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LifeCell Corporation
- Inspection Date: 2019-06-14
- Product Type: other
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/lifecell-corporation/b7889dd5-f0be-423d-bb9d-53c6d14b4a10)
- [483 - 2017-08-25](https://www.keypedia.com/records/483/lifecell-corporation/d2a7692c-fd4c-44b6-b4e4-b05a9a6be045)

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/lifecell-corporation/befaec51-e133-4222-ad7e-0cf8e59f5d23

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248