Hereon Pharmaceuticals, LLC
FDA inspection history in Emigsville, Pennsylvania, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Emigsville, Pennsylvania.
Cited most
Across all Hereon Pharmaceuticals observations on file
- 21 CFR 211.160(b)(4)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment1
The complete Hereon Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Emigsville, Pennsylvania
One Form 483 · 2019 · 3 observations
Latest: Form 483, Apr 5, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-04-05 | 483 Form 483 | Emigsville, Pennsylvania | 3 | $99 |
Investigators on these documents
FEI number 2522638 · most recent document Apr 5, 2019
About Hereon Pharmaceuticals, LLC
How many FDA Form 483s has Hereon Pharmaceuticals, LLC received?
FDA Intel has 1 Form 483 on file for Hereon Pharmaceuticals, LLC; the most recent is dated Apr 5, 2019.
When was Hereon Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Hereon Pharmaceuticals, LLC is a Form 483 dated Apr 5, 2019, for the site in Emigsville, Pennsylvania.
What did FDA cite at Hereon Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Hereon Pharmaceuticals, LLC are 21 CFR 211.160(b)(4) (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 1 time.