Quagen Pharmaceuticals LLC
FDA inspection history in West Caldwell, New Jersey, 2019 to 2020
- 3
- Form 483s
Every document, by year
- Form 483
2019: two Form 483s; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20Three Form 483s, at West Caldwell, New Jersey.
- 2019The longest 483 on file: 3 observations over 4 pages at West Caldwell, New Jersey.
Cited most
Across all Quagen Pharmaceuticals observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 211.28Personnel responsibilities1
The complete Quagen 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
West Caldwell, New Jersey
Three Form 483s · 2019 to 2020 · 6 observations
Latest: Form 483, Oct 26, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-10-26 | 483 Form 483 | West Caldwell, New Jersey | 2 | $99 |
| 2019-11-08 | 483 Form 483 | West Caldwell, New Jersey | 3 | $99 |
| 2019-03-15 | 483 Form 483 | West Caldwell, New Jersey | 1 | $99 |
Investigators on these documents
FEI number 3012403297 · most recent document Oct 26, 2020
About Quagen Pharmaceuticals LLC
How many FDA Form 483s has Quagen Pharmaceuticals LLC received?
FDA Intel has 3 Form 483s on file for Quagen Pharmaceuticals LLC; the most recent is dated Oct 26, 2020.
When was Quagen Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for Quagen Pharmaceuticals LLC is a Form 483 dated Oct 26, 2020, for the site in West Caldwell, New Jersey.
What did FDA cite at Quagen Pharmaceuticals LLC?
The regulations cited most in the observations on file for Quagen Pharmaceuticals LLC are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.