# FDA 483 - Renaissance Lakewood, LLC - June 06, 2023

Source: https://www.keypedia.com/records/483/renaissance-lakewood-llc/a205d385-4bcf-413f-bf08-4e99a0204006

> FDA 483 for Renaissance Lakewood, LLC on June 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Renaissance Lakewood, LLC
- Inspection Date: 2023-06-06
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Renaissance Lakewood, LLC in Lakewood, NJ, revealed significant deficiencies across multiple systems. Observations included poorly maintained stability chambers, inadequate documentation for stability sample handling, unjustified deviations in production processes, and unaddressed equipment leaks linked to microbial contamination. These issues indicate a lack of robust quality control and proper equipment maintenance.

## Related Documents

- [483 - 2019-08-22](https://www.keypedia.com/records/483/renaissance-lakewood-llc/d4e56ad2-5db7-4135-b99a-37d54cbb6d30)
- [EIR - 2023-05-24](https://www.keypedia.com/records/eir/renaissance-lakewood-llc/a925c3d5-bd03-4755-8d8d-7268ad2a728a)

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/renaissance-lakewood-llc/8b2036d4-96e6-4cb1-84fc-6baf5111e9f7

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