Horizon Pharmaceuticals has been warned by the Food and Drug Administration (FDA) to better respond on resolving certain issues it had in its drug manufacturing facilities, that the FDA pointed out after an inspection in 2015.
The FDA sent a warning letter to the drugmaker on January 10 2017, in which it said that it has failed in preventing microbiological contamination of drug products.
The FDA has said that Horizon released lots of previously non-sterile Saljet bottles without positive sterility results.
“Without a meaningful scientific justification, your firm released these lots following a retest,” the FDA has said.
Furthermore, the FDA stated that there was a lack of management oversight to ensure a thorough investigation of these non-sterile batches, and prevent their distribution. The FDA said it acknowledged Horizon’s commitment to conduct a retrospective review for this failure, but that it was not enough. “Your response fails to provide adequate corrections,” the FDA said regarding non-sterile bottles of Saljet.
In addition, the FDA has also said that Horizon failed 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.
Horizon has been given 15 days to respond to the warning letter with scientifically justified conclusions, and to summarize improvements made to the investigations and CAPA management procedures. FDA has also suggested an advisor to resolve the issues.
FDA also said that it may withhold approval of pending drug applications from the Florida factory until these violations are corrected. “We may re-inspect to verify that you have completed your corrective actions. We may also refuse your requests for export certificates,” the FDA has said.
We’ve sent an email to Horizon Pharmaceuticals asking for their comment.