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•United States

Nesher Pharmaceuticals (USA) LLC, Saint Louis, MO – FDA Inspections

Inspection records and compliance data for Nesher Pharmaceuticals (USA) LLC in Saint Louis, Missouri. 8 FDA inspections on record (1 OAI), 2 Form 483s, last inspected August 12, 2021.

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Company Profile

This profile covers Nesher Pharmaceuticals (USA) LLC based in Saint Louis, Missouri, United States.

FDA Inspection History

FDA inspections
8
OAI
1
VAI
6
NAI
1
Form 483s
2
Warning letters
0

First inspected February 2, 2009. Last inspected August 12, 2021.

Most cited issue areas

  • Adequate space lacking to prevent mix-ups and contamination1 inspection
  • Calibration/Inspection/Checking not done1 inspection
  • Changes to Procedures Not Reviewed, Approved1 inspection

FDA inspections (8)

DateResultFDA center(s)Insp. #
August 12, 2021VAIHuman Drugs · Drug Quality Assurance1151305
May 31, 2019VAIHuman Drugs · Drug Quality Assurance1095659
February 3, 2017VAIHuman Drugs · Drug Quality Assurance1002432
May 7, 2015VAIHuman Drugs · Drug Quality Assurance925349
November 7, 2013NAIHuman Drugs · Drug Quality Assurance855762
December 6, 2012VAIHuman Drugs · Drug Quality Assurance811438
February 11, 2011VAIHuman Drugs · Drug Quality Assurance709300
February 2, 2009OAIHuman Drugs · Drug Quality Assurance554855
FDA documents

Form 483s (1)

  • Form 483s · May 31, 2019
People (2)
Wayne D. Mcgrath
Person
Michele Perry-Williams
Person
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Company Information

Name

Nesher Pharmaceuticals (USA) LLC

FEI Number

1937079

Address

2303 Schuetz Rd, Saint Louis, Missouri 63146, United States

Country

United States

ID: d0fd36a5-057e-46eb-8fb3-828cd2c27388

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