# FDA 483 - Renaissance Lakewood, LLC - August 22, 2019

Source: https://www.globalkeysolutions.net/records/483/renaissance-lakewood-llc/d4e56ad2-5db7-4135-b99a-37d54cbb6d30

> FDA 483 for Renaissance Lakewood, LLC on August 22, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Renaissance Lakewood, LLC
- Inspection Date: 2019-08-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Renaissance Lakewood, LLC, a contract pharmaceutical manufacturer in Lakewood, NJ, revealed two significant observations. The firm failed to thoroughly investigate out-of-specification drug product, specifically (b)(4) Oral Spray exhibiting a yellowish color, without establishing a definitive root cause. Additionally, the inspection found that the firm did not determine actual and theoretical yields for drug products, hindering proper process control and deviation investigations.

## Related Documents

- [EIR - 2023-05-24](https://www.globalkeysolutions.net/records/eir/renaissance-lakewood-llc/a925c3d5-bd03-4755-8d8d-7268ad2a728a)
- [483 - 2023-06-06](https://www.globalkeysolutions.net/records/483/renaissance-lakewood-llc/a205d385-4bcf-413f-bf08-4e99a0204006)

## Related Officers

- [Russell J. Glapion](https://www.globalkeysolutions.net/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

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

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