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•United States

Horizon Pharmaceuticals, Inc., Riviera Beach, FL – FDA Inspections

Inspection records and compliance data for Horizon Pharmaceuticals, Inc. in Riviera Beach, Florida. 7 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected February 16, 2024.

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Company Profile

This profile covers Horizon Pharmaceuticals, Inc. based in Riviera Beach, Florida, United States.

FDA Inspection History

FDA inspections
7
OAI
1
VAI
5
NAI
1
Form 483s
2
Warning letters
1

First inspected July 15, 2009. Last inspected February 16, 2024.

Most cited issue areas

  • Procedures for sterile drug products3 inspections
  • Procedures not in writing, fully followed3 inspections
  • Authority lacking to review records, investigate errors2 inspections

FDA inspections (7)

DateResultFDA center(s)Insp. #
February 16, 2024VAIHuman Drugs · Drug Quality Assurance1230144
August 17, 2018VAIHuman Drugs · Drug Quality Assurance1062610
August 5, 2017VAIHuman Drugs · Drug Quality Assurance1021385
November 5, 2015OAIHuman Drugs · Drug Quality Assurance947268
May 17, 2013VAIHuman Drugs · Drug Quality Assurance834098
September 26, 2011VAIHuman Drugs · Drug Quality Assurance747247
July 15, 2009NAIHuman Drugs · Drug Quality Assurance600866
FDA documents

Form 483s (1)

  • Form 483s · February 16, 2024

Warning Letters (1)

  • Warning Letters · November 5, 2015
People (3)
Susan M. Turcovski
Person
Steven A. Brettler
Person
Joanne E. King
Person
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Company Information

Name

Horizon Pharmaceuticals, Inc.

FEI Number

3000718824

Address

971 W 15th St, Riviera Beach, Florida 33404, United States

Country

United States

ID: fd0a8a3e-f0f8-4aa3-ac41-22ba29eb9830

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Contact
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🇪🇺+48 532-447-507
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