Eurofarma Laboratorios S/A
Form 483 issued September 20, 2022 · Itapevi, Brazil
- Inspection
- Sep 12 – Sep 20, 2022
- Investigator
- Sony Mathews
- Observations
- 5
- Pages
- 4
- FEI number
- 3009538725
In short: On September 20, 2022, FDA issued a Form 483 with 5 observations to Eurofarma Laboratorios S/A in Itapevi, SAO PAULO (FEI 3009538725) after an inspection that ran Sep 12 – Sep 20, 2022. The investigator was Sony Mathews. Most observations concern facilities & equipment and production.
At a glance
4 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Input to and output from are not checked for accuracy. Electronic records are used, but they…
- 04
Equipment for adequate control over air pressure, micro-organisms, humidity and temperature is not provided when appropriate…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmEurofarma Laboratorios S/A history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eurofarma Laboratorios S/A?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Eurofarma Laboratorios S/A?
Sony Mathews is named on this Form 483, for the inspection of Sep 12 – Sep 20, 2022. Each investigator has a profile showing what they cite most.
When was Eurofarma Laboratorios S/A inspected by FDA?
The inspection ran Sep 12 – Sep 20, 2022, and the Form 483 is dated September 20, 2022.
How do I get the full Form 483 for Eurofarma Laboratorios S/A?
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.