Eriochem S.A.
Form 483 issued November 5, 2019 · Colonia Avellaneda, Argentina
- Inspection
- Oct 28 – Nov 5, 2019
- Investigator
- Liming Zhang
- Observations
- 3
- Pages
- 2
- FEI number
- 3004363207
In short: On November 5, 2019, FDA issued a Form 483 with 3 observations to Eriochem S.A. in Colonia Avellaneda, Entre Rios (FEI 3004363207) after an inspection that ran Oct 28 – Nov 5, 2019. The investigator was Liming Zhang. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Liming Zhang
19 documents · 2014–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmEriochem S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42(c)(10)(vi)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eriochem S.A.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Eriochem S.A.?
Liming Zhang is named on this Form 483, for the inspection of Oct 28 – Nov 5, 2019. Each investigator has a profile showing what they cite most.
When was Eriochem S.A. inspected by FDA?
The inspection ran Oct 28 – Nov 5, 2019, and the Form 483 is dated November 5, 2019.
How do I get the full Form 483 for Eriochem 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.