Curexa
Form 483 issued September 9, 2022 · Egg Harbor Township, New Jersey
- Inspection
- Aug 29 – Sep 9, 2022
- Investigators
- Jessica S. Estriplet· Sena G. Dissmeyer
- Observations
- 3
- Pages
- 6
- FEI number
- 3011761882
In short: On September 9, 2022, FDA issued a Form 483 with 3 observations to Curexa in Egg Harbor Township, New Jersey (FEI 3011761882) after an inspection that ran Aug 29 – Sep 9, 2022. The investigators were Jessica S. Estriplet and Sena G. Dissmeyer. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Observations span 1 system, led by production.
Most cited: FDCA 501(a)(2)(A) (2×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 02FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate cleaning of…
- 03
Your fnm released diug product in which the strength differs from, or its purity or quality…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmCurexa history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Curexa?
FDA listed 3 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Curexa?
Jessica S. Estriplet and Sena G. Dissmeyer are named on this Form 483, for the inspection of Aug 29 – Sep 9, 2022. Each investigator has a profile showing what they cite most.
When was Curexa inspected by FDA?
The inspection ran Aug 29 – Sep 9, 2022, and the Form 483 is dated September 9, 2022.
How do I get the full Form 483 for Curexa?
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.