Curexa
Form 483 issued September 27, 2020 · Egg Harbor, New Jersey
- Inspection
- Sep 13, 2018 – Sep 27, 2020
- Investigator
- Frederick Razzaghi
- Observations
- 1
- Pages
- 1
- FEI number
- 3011761882
In short: On September 27, 2020, FDA issued a Form 483 with 1 observation to Curexa in Egg Harbor, New Jersey (FEI 3011761882) after an inspection that ran Sep 13, 2018 – Sep 27, 2020. The investigator was Frederick Razzaghi. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Curexa?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Curexa?
Frederick Razzaghi is named on this Form 483, for the inspection of Sep 13, 2018 – Sep 27, 2020. Each investigator has a profile showing what they cite most.
When was Curexa inspected by FDA?
The inspection ran Sep 13, 2018 – Sep 27, 2020, and the Form 483 is dated September 27, 2020.
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.