Eugia Pharma Specialities Limited
Form 483 issued December 14, 2018 · Medak District, India
- Inspection
- Dec 3 – Dec 14, 2018
- Investigator
- Jose A. Cruz-Gonzalez
- Observations
- 1
- Pages
- 12
- FEI number
- 3008461619
In short: On December 14, 2018, FDA issued a Form 483 with 1 observation to Eugia Pharma Specialities Limited in Medak District, India (FEI 3008461619) after an inspection that ran Dec 3 – Dec 14, 2018. The investigator was Jose A. Cruz-Gonzalez. 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(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmEugia Pharma Specialities Limited history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia Pharma Specialities Limited?
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 Eugia Pharma Specialities Limited?
Jose A. Cruz-Gonzalez is named on this Form 483, for the inspection of Dec 3 – Dec 14, 2018. Each investigator has a profile showing what they cite most.
When was Eugia Pharma Specialities Limited inspected by FDA?
The inspection ran Dec 3 – Dec 14, 2018, and the Form 483 is dated December 14, 2018.
How do I get the full Form 483 for Eugia Pharma Specialities Limited?
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.