Quagen Pharmaceuticals LLC
Form 483 issued October 26, 2020 · West Caldwell, New Jersey
- Inspection
- Oct 13 – Oct 26, 2020
- Investigator
- Monika Borkowska
- Observations
- 2
- Pages
- 2
- FEI number
- 3012403297
In short: On October 26, 2020, FDA issued a Form 483 with 2 observations to Quagen Pharmaceuticals LLC in West Caldwell, New Jersey (FEI 3012403297) after an inspection that ran Oct 13 – Oct 26, 2020. The investigator was Monika Borkowska. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.28 (personnel responsibilities).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.28 (1×) · 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
Protective apparel is not worn as necessary to protect…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
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 211.28
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quagen Pharmaceuticals LLC?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.28 (personnel responsibilities). The opening words of each observation are shown on this page.
Who inspected Quagen Pharmaceuticals LLC?
Monika Borkowska is named on this Form 483, for the inspection of Oct 13 – Oct 26, 2020. Each investigator has a profile showing what they cite most.
When was Quagen Pharmaceuticals LLC inspected by FDA?
The inspection ran Oct 13 – Oct 26, 2020, and the Form 483 is dated October 26, 2020.
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.