# FDA 483 - Horizon Pharmaceuticals, Inc. - February 16, 2024

Source: https://www.keypedia.com/records/483/horizon-pharmaceuticals-inc/529dd79c-192a-412c-8785-180914914572

> FDA 483 for Horizon Pharmaceuticals, Inc. on February 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Horizon Pharmaceuticals, Inc.
- Inspection Date: 2024-02-16
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Horizon Pharmaceuticals, Inc., a sterile drug manufacturer in Riviera Beach, FL, received a Form 483 citing significant deficiencies across its quality system, laboratory controls, and facilities. The inspection revealed a lack of adequate quality control unit oversight, incomplete investigations into environmental monitoring excursions, and failures in complaint handling, vendor qualification, and batch record review. These issues indicate a systemic breakdown in ensuring the quality and sterility of its arformoterol tartrate inhalation solution.

## Related Documents

- [WARNING_LETTER - 2015-11-05](https://www.keypedia.com/records/warning_letter/horizon-pharmaceuticals-inc/712a6440-26e0-4f24-b92f-09f20e4af78a)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/horizon-pharmaceuticals-inc/fd0a8a3e-f0f8-4aa3-ac41-22ba29eb9830

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6