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•United States

PharmScript, LLC, Somerset, NJ – FDA Inspections

Inspection records and compliance data for PharmScript, LLC in Somerset, New Jersey. 2 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected August 07, 2018.

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Company Profile

This profile covers PharmScript, LLC based in Somerset, New Jersey, United States.

FDA Inspection History

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

First inspected October 24, 2016. Last inspected August 7, 2018.

Most cited issue areas

  • Beta-lactam drugs, inadequate sanitation1 inspection
  • Exposure of personnel in aspectic processing1 inspection
  • Inadequate sporicidal agents, cleanroom and ISO 5 area1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
August 7, 2018Not classifiedHuman Drugs · Drug Quality Assurance1061337
October 24, 2016OAIHuman Drugs · Drug Quality Assurance993187
FDA documents

Form 483s (2)

  • Form 483s · August 7, 2018
  • Form 483s · October 24, 2016

Warning Letters (1)

  • Warning Letters · October 24, 2016

Other FDA documents (1)

  • Other FDA documents · July 30, 2018
People (5)
Liane Krueger
Person
Tonia F. Bernard
Person
Diana Amador-Toro
Person
Sena G. Dissmeyer
Person
Russell J. Glapion
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Merck & Company
Janssen Research & Development, LLC
Dr. Reddy'S Laboratories
Fosun Pharma USA Inc.
Drugs Are Us, Inc., dba Hopewell Pharmacy
Colonia Care Pharmacy
Ausberto B. Hidalgo, M.D.
Pablo H. Vivas, M.D.
Angela M. Stupi, M.D.
Blount Discount Pharmacy, Inc.
Company Information

Name

PharmScript, LLC

FEI Number

3012837733

Address

150 Pierce St, Somerset, New Jersey 08873, United States

Country

United States

ID: d717e7ef-a383-48fa-830e-970a01f0ddd4

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