In the thirdquarter of 2009 an FDA cGMP drug inspection was performed in July, 2009 where there were 0 items identified (No FDA Form 483 issued). This is the second time in the most recent four inspections where no items were identified. This further emphasizes the continued commitment to Quality at Horizon Pharmaceuticals, Inc.
In the second quarter of 2009, global suppliers of health and safety productsfor industrial workers/consumers, joined with Horizon Pharmaceuticals for contract manufacturing. With this, the successful manufacture of unit dose 1oz, 16oz and 32oz sterile eye and skin flush products began and successfully delivered to clients, which provides products for a multitude of industries. Each batch was tested according to standard test methods, including sterility, and subsequently released to partners with high Quality standard.
In early 2009, on a short time line, and with high quality, Horizon was able to manufacture products for one of the top 15 US science-based pharmaceutical companies, with global diversified technology. The company has significant presence in the Health Care field with products in areas such as microbiology/food safety, medical devices, and personal care. Each batch of product manufactured by Horizon Pharmaceuticals, Inc. is tested by our Quality Control Department to ensure customer and regulatory requirements are met.
Since late 2008 Horizon Pharmaceuticals has successfully supplied products including eye drops and gel to a top US pharmaceutical company, involved in the area of sterile ophthalmic products, 100% on time for delivery to domestic and international markets.
Certification for ISO 13485:2003: Assessments in October 2008 (Stage I) and December 2008 (Stage II) resulted in a recommendation for certification by the two auditors.The recommendation, provided by the auditors, moves directly to the certification body (BSI) and Certification received on 2/26/2009, stating compliance with ISO Standard 13485:2003, specific to Medical Devices.
Florida State Inspection: The Florida Department of Health, Division of Medical Quality Assurance, inspected The Headquarters and Production facilities. The inspections were successful and no observations were found. The licenses for the facilities were issued in October 2008.