Curexa
Form 483 issued October 9, 2020 · Egg Harbor Township, New Jersey
- Inspection
- Aug 26 – Oct 9, 2020
- Investigators
- Nancy M. Espinal· William J. Muszynski
- Observations
- 3
- Pages
- 4
- FEI number
- 3011761882
In short: On October 9, 2020, FDA issued a Form 483 with 3 observations to Curexa in Egg Harbor Township, New Jersey (FEI 3011761882) after an inspection that ran Aug 26 – Oct 9, 2020. The investigators were Nancy M. Espinal and William J. Muszynski. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
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…
- 02
Laboratory analysis of hormone sample determined the strength was below…
- 03
Buildings used in the processing of a chug product are not maintained in a…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) 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 211.192
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 quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Curexa?
Nancy M. Espinal and William J. Muszynski are named on this Form 483, for the inspection of Aug 26 – Oct 9, 2020. Each investigator has a profile showing what they cite most.
When was Curexa inspected by FDA?
The inspection ran Aug 26 – Oct 9, 2020, and the Form 483 is dated October 9, 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.