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Cosette Pharmaceuticals NC Laboratories, LLC, Lincolnton, NC – FDA Inspections

Inspection records and compliance data for Cosette Pharmaceuticals NC Laboratories, LLC in Lincolnton, North Carolina. 6 FDA inspections on record, 1 Form 483, last inspected July 21, 2023.

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Company Profile

This profile covers Cosette Pharmaceuticals NC Laboratories, LLC based in Lincolnton, North Carolina, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
1
NAI
5
Form 483s
1
Warning letters
0

First inspected March 4, 2011. Last inspected July 21, 2023.

Most cited issue areas

  • Incoming material area1 inspection
  • Written Procedures Not Followed1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
July 21, 2023VAIHuman Drugs · Drug Quality Assurance1210546
November 30, 2017NAIHuman Drugs · Drug Quality Assurance1035767
July 29, 2016NAIHuman Drugs · Drug Quality Assurance983395
February 24, 2014NAIHuman Drugs · Drug Quality Assurance870025
September 25, 2012NAIHuman Drugs · Drug Quality Assurance801611
March 4, 2011NAIHuman Drugs · Drug Quality Assurance713187
FDA documents

Form 483s (1)

  • Form 483s · July 21, 2023
People (2)
Megan T. Ziegler
Person
Harshal J. Desai
Person
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Company Information

Name

Cosette Pharmaceuticals NC Laboratories, LLC

FEI Number

1053439

Address

1877 Kawai Rd, Lincolnton, North Carolina 28092, United States

Country

United States

ID: 4f90e360-99ea-4457-a022-4950a8ea7644

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