Horizon Pharmaceuticals, Inc.
Form 483 issued February 16, 2024 · Riviera Beach, Florida
- Inspection
- Feb 5 – Feb 16, 2024
- Observations
- 9
- Pages
- 11
- FEI number
- 3000718824
In short: On February 16, 2024, FDA issued a Form 483 with 9 observations to Horizon Pharmaceuticals, Inc. in Riviera Beach, Florida (FEI 3000718824) after an inspection that ran Feb 5 – Feb 16, 2024. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 211.22(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to fully investigate…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Complaint records are deficient in that they do not include the findings of the…
- 04
The quality control unit lacks responsibility for approving or rejecting drug products processed under…
This inspection in context
Questions about this 483
What did FDA find at Horizon Pharmaceuticals, Inc.?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Horizon Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Feb 5 – Feb 16, 2024, and the Form 483 is dated February 16, 2024.
How do I get the full Form 483 for Horizon Pharmaceuticals, Inc.?
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