Amneal Pharmaceuticals, Llc
FDA inspection history in Paterson, New Jersey, 2017
- 1
- Form 483
Every document, by year
- Form 483
2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Paterson, New Jersey.
Cited most
Across all Amneal Pharmaceuticals observations on file
- 21 CFR 211.67(b)Equipment cleaning and maintenance2
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.56(a)Sanitation1
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment1
The complete Amneal Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Paterson, New Jersey
One Form 483 · 2017 · 5 observations
Latest: Form 483, Oct 25, 2017 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-10-25 | 483 Form 483 | Paterson, New Jersey | 5 | $99 |
Investigators on these documents
FEI number 3003792057 · most recent document Oct 25, 2017
About Amneal Pharmaceuticals, Llc
How many FDA Form 483s has Amneal Pharmaceuticals, Llc received?
FDA Intel has 1 Form 483 on file for Amneal Pharmaceuticals, Llc; the most recent is dated Oct 25, 2017.
When was Amneal Pharmaceuticals, Llc last inspected by FDA?
The most recent FDA inspection document on file for Amneal Pharmaceuticals, Llc is a Form 483 dated Oct 25, 2017, for the site in Paterson, New Jersey.
What did FDA cite at Amneal Pharmaceuticals, Llc?
The regulations cited most in the observations on file for Amneal Pharmaceuticals, Llc are 21 CFR 211.67(b) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time; 21 CFR 211.56(a) (Sanitation), 1 time.