Company
United StatesHorizon 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.
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)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 16, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1230144 |
| August 17, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1062610 |
| August 5, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1021385 |
| November 5, 2015 | OAI | Human Drugs · Drug Quality Assurance | 947268 |
| May 17, 2013 | VAI | Human Drugs · Drug Quality Assurance | 834098 |
| September 26, 2011 | VAI | Human Drugs · Drug Quality Assurance | 747247 |
| July 15, 2009 | NAI | Human Drugs · Drug Quality Assurance | 600866 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
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