Quagen Pharmaceuticals LLC
Form 483 issued March 15, 2019 · West Caldwell, New Jersey
- Inspection
- Feb 26 – Mar 15, 2019
- Investigators
- Monika Borkowska· Yvesna Blaise
- Observations
- 1
- Pages
- 1
- FEI number
- 3012403297
In short: On March 15, 2019, FDA issued a Form 483 with 1 observation to Quagen Pharmaceuticals LLC in West Caldwell, New Jersey (FEI 3012403297) after an inspection that ran Feb 26 – Mar 15, 2019. The investigators were Monika Borkowska and Yvesna Blaise. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Monika Borkowska
6 documents · 2018–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmQuagen Pharmaceuticals LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quagen Pharmaceuticals LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Quagen Pharmaceuticals LLC?
Monika Borkowska and Yvesna Blaise are named on this Form 483, for the inspection of Feb 26 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Quagen Pharmaceuticals LLC inspected by FDA?
The inspection ran Feb 26 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Quagen Pharmaceuticals LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.