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# FDA Finds CGMP Violations at Horizon Pharmaceuticals
- URL: https://www.fdaweb.com/fda-finds-cgmp-violations-at-horizon-pharmaceuticals/
- Published: 2017-01-17T12:00:00.000Z
- Updated: 2026-09-14T22:00:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137733

A 10/27-11/5/15 FDA inspection at Horizon Pharmaceuticals, Riviera Beach, FL, found significant violations of current good manufacturing regulations for finished pharmaceuticals, according to a just-released 12/23/16 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm536715.htm?ref=fdaweb.com) from the agency’s Florida District Office. Specific violations included: 

- failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch, or any of its components, to meet any of its specifications, whether or not the batch was already distributed; and
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.

“Based upon the nature of the violations we identified at your firm, and your failure to correct repeat violations,” the letter says, “we recommend engaging a consultant … to assist your firm in meeting CGMP requirements. The consultant’s work should include, but not be limited to, a comprehensive evaluation of the suitability of your aseptic processing facilities and processes, and the sufficiency of management oversight of manufacturing and quality.”

Horizon was told to summarize improvements made to the investigations and CAPA (corrective and preventive actions) procedures to ensure that its quality unit reviews each batch before release. It was told to include its retrospective review of all failure investigations to ensure that the conclusions were scientifically justified. It also is to specify what it has done since the inspection to correct the violations and prevent their recurrence.