# Renaissance Lakewood, LLC – FDA 483, Jul 29, 2026

Source: https://www.keypedia.com/records/483/renaissance-lakewood-llc/29ce4e49-4b8f-4753-a930-9ff9e8049263

> FDA 483 for Renaissance Lakewood, LLC on July 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Renaissance Lakewood, LLC
- Inspection Date: 2026-07-29
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Renaissance Lakewood, LLC, a drug manufacturer in Lakewood, NJ, revealed significant deficiencies in their production and process controls. The firm failed to establish adequate written procedures, specifically concerning the visualization of unidirectional airflow during aseptic filling operations and the validation of a visual inspection method. These issues indicate a lack of robust quality assurance practices that could impact drug product identity, strength, purity, and quality.

## Related Documents

- [483 - 2023-06-06](https://www.keypedia.com/records/483/renaissance-lakewood-llc/a205d385-4bcf-413f-bf08-4e99a0204006) — date: June 6, 2023
- [EIR - 2023-05-24](https://www.keypedia.com/records/eir/renaissance-lakewood-llc/a925c3d5-bd03-4755-8d8d-7268ad2a728a) — date: May 24, 2023
- [483 - 2019-08-22](https://www.keypedia.com/records/483/renaissance-lakewood-llc/d4e56ad2-5db7-4135-b99a-37d54cbb6d30) — date: August 22, 2019

## Related Officers

- [Alisha B. Patel](https://www.keypedia.com/people/alisha-b-patel/3c106dac-0e0d-41f2-9f7a-69982d4e6579)
- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

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