Quagen Pharmaceuticals LLC
Form 483 issued November 8, 2019 · West Caldwell, New Jersey
- Inspection
- Nov 4 – Nov 8, 2019
- Investigator
- Niketa Patel
- Observations
- 3
- Pages
- 4
- FEI number
- 3012403297
In short: On November 8, 2019, FDA issued a Form 483 with 3 observations to Quagen Pharmaceuticals LLC in West Caldwell, New Jersey (FEI 3012403297) after an inspection that ran Nov 4 – Nov 8, 2019. The investigator was Niketa Patel. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quagen Pharmaceuticals LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Quagen Pharmaceuticals LLC?
Niketa Patel is named on this Form 483, for the inspection of Nov 4 – Nov 8, 2019. Each investigator has a profile showing what they cite most.
When was Quagen Pharmaceuticals LLC inspected by FDA?
The inspection ran Nov 4 – Nov 8, 2019, and the Form 483 is dated November 8, 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.