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•United States

King Pharmaceuticals LLC, Rochester, MI – FDA Inspections

Inspection records and compliance data for King Pharmaceuticals LLC in Rochester, Michigan. 11 FDA inspections on record (2 OAI), 2 Form 483s, last inspected February 18, 2025.

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Company Profile

This profile covers King Pharmaceuticals LLC based in Rochester, Michigan, United States.

FDA Inspection History

FDA inspections
11
OAI
2
VAI
8
NAI
1
Form 483s
2
Warning letters
0

First inspected November 25, 2008. Last inspected February 18, 2025.

Most cited issue areas

  • Procedures not in writing, fully followed6 inspections
  • Procedures for sterile drug products3 inspections
  • Written procedures not established/followed3 inspections

FDA inspections (11)

DateResultFDA center(s)Insp. #
February 18, 2025OAIHuman Drugs · Drug Quality Assurance1261579
October 21, 2019VAIHuman Drugs · Drug Quality Assurance1107986
March 14, 2018NAIHuman Drugs · Drug Quality Assurance1049269
November 21, 2016VAIHuman Drugs · Drug Quality Assurance1000037
May 15, 2015VAIHuman Drugs · Drug Quality Assurance926523
August 26, 2014VAIHuman Drugs · Drug Quality Assurance892667
December 13, 2012VAIHuman Drugs · Drug Quality Assurance807158
June 15, 2012VAIHuman Drugs · Drug Quality Assurance786574
March 16, 2011VAIHuman Drugs · Drug Quality Assurance713757
January 19, 2010OAIHuman Drugs · Drug Quality Assurance638769
November 25, 2008VAIHuman Drugs · Drug Quality Assurance548229
FDA documents

Form 483s (2)

  • Form 483s · February 18, 2025
  • Form 483s · October 21, 2019
People (4)
Alan M. Roberts
Person
Jeffrey D. Meng
Person
Nicholas J. Presto
Person
Jacob G. Lutz
Person
Related Companies (10)

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Actavis Laboratories FL, Inc.
Rovi Pharma Industrial Services S.A.
Sanofi Winthrop Industrie
Daiichi Sankyo Europe GmbH
PF Soins de Sante SRI
Janssen - Cilag Spa.
Company Information

Name

King Pharmaceuticals LLC

FEI Number

1876582

Canada Business Number

814881744

Address

1200 Parkdale Rd, Rochester, Michigan 48307, United States

Country

United States

ID: d90c79dd-4325-4185-bf42-87c7f116f6c5

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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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