Horizon Pharmaceuticals, Inc.
FDA inspection history in Riviera Beach, Florida, 2016 to 2024
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2016: one warning letter; 2018: one close-out letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18One warning letter and one close-out letter, at Riviera Beach, Florida.
- 2024One Form 483, at Riviera Beach, Florida.
Cited most
Across all Horizon Pharmaceuticals observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit3
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.194(a)(8)Laboratory records1
- 21 CFR 211.198(b)(2)Complaint files1
The complete Horizon Pharmaceuticals file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Riviera Beach, Florida
One Form 483, one close-out letter and one warning letter · 2016 to 2024 · 9 observations
Latest: Form 483, Feb 16, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-16 | 483 Form 483 | Riviera Beach, Florida | 9 | $99 |
| 2018-02-19 | Close-out Close-out letter | Riviera Beach, Florida | — | $99 |
| 2016-12-23 | Warning letter Warning letter | Riviera Beach, Florida | — | $99 |
FEI number 3000718824 · most recent document Feb 16, 2024
About Horizon Pharmaceuticals, Inc.
How many FDA Form 483s has Horizon Pharmaceuticals, Inc. received?
FDA Intel has 1 Form 483 on file for Horizon Pharmaceuticals, Inc.; the most recent is dated Feb 16, 2024.
When was Horizon Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Horizon Pharmaceuticals, Inc. is a Form 483 dated Feb 16, 2024, for the site in Riviera Beach, Florida.
What did FDA cite at Horizon Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Horizon Pharmaceuticals, Inc. are 21 CFR 211.22(a) (Responsibilities of quality control unit), 3 times; 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.188 (Batch production and control records), 1 time.
Has Horizon Pharmaceuticals, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Horizon Pharmaceuticals, Inc.; the most recent is dated Dec 23, 2016.