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•United States

Renaissance Lakewood, LLC, Lakewood, NJ – FDA Inspections

Inspection records and compliance data for Renaissance Lakewood, LLC in Lakewood, New Jersey. 14 FDA inspections on record (1 OAI), 4 Form 483s, last inspected July 29, 2026.

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Company Profile

This profile covers Renaissance Lakewood, LLC based in Lakewood, New Jersey, United States.

FDA Inspection History

FDA inspections
14
OAI
1
VAI
6
NAI
6
Unclassified
1
Form 483s
4
Warning letters
0

First inspected November 3, 2009. Last inspected July 29, 2026.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Control procedures to monitor and validate performance1 inspection
  • Failure to meet specifications1 inspection

FDA inspections (14)

DateResultFDA center(s)Insp. #
July 29, 2026Not classifiedHuman Drugs · Drug Quality Assurance1327338
June 6, 2023VAIHuman Drugs · Drug Quality Assurance1209603
August 22, 2019VAIHuman Drugs · Drug Quality Assurance1100331
March 15, 2018VAIHuman Drugs · Drug Quality Assurance1045720
April 26, 2017NAIHuman Drugs · Drug Quality Assurance1009890
June 1, 2016NAIHuman Drugs · Drug Quality Assurance973346
February 6, 2015VAIHuman Drugs · Drug Quality Assurance911163
November 4, 2014NAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance903203
January 17, 2013NAIHuman Drugs · Drug Quality Assurance814484
March 7, 2012OAIHuman Drugs · Drug Quality Assurance770948
August 10, 2011VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices738657
June 15, 2010NAIHuman Drugs · Drug Quality Assurance666738
April 28, 2010VAIHuman Drugs · Drug Quality Assurance655482
November 3, 2009NAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance626483
FDA documents

Form 483s (3)

  • Form 483s · July 29, 2026
  • Form 483s · June 6, 2023
  • Form 483s · August 22, 2019

EIRs (1)

  • EIRs · May 24, 2023
People (5)
Russell J. Glapion
Person
Nerizza Guerin
Person
Serge Maltais
Person
Karishma G. Gopaul
Person
Adetutu M. Gidado
Person
Related Companies (10)

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Rottendorf Pharma Gmbh
Tris Pharma Inc.
Catalent CTS, LLC
Jerome Stevens Pharmaceuticals, Inc.
Ferndale Laboratories, Inc.
Ferring Production Inc.
Lyne Laboratories, Inc.
Company Information

Name

Renaissance Lakewood, LLC

FEI Number

2242829

Address

1200 Paco Way, Lakewood, New Jersey 08701, United States

Country

United States

ID: 8b2036d4-96e6-4cb1-84fc-6baf5111e9f7

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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