Eugia Pharma Specialities Limited
Form 483 issued September 16, 2016 · Medak District, India
- Inspection
- Sep 6 – Sep 16, 2016
- Investigator
- Scott Ballard
- Observations
- 2
- Pages
- 4
- FEI number
- 3008461619
In short: On September 16, 2016, FDA issued a Form 483 with 2 observations to Eugia Pharma Specialities Limited in Medak District, India (FEI 3008461619) after an inspection that ran Sep 6 – Sep 16, 2016. The investigator was Scott Ballard. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 314.81 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An Field Alert Report was not submitted within three working days of receipt of information concerning…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Scott Ballard
30 documents · 2011–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 314.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eugia Pharma Specialities Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports). The opening words of each observation are shown on this page.
Who inspected Eugia Pharma Specialities Limited?
Scott Ballard is named on this Form 483, for the inspection of Sep 6 – Sep 16, 2016. Each investigator has a profile showing what they cite most.
When was Eugia Pharma Specialities Limited inspected by FDA?
The inspection ran Sep 6 – Sep 16, 2016, and the Form 483 is dated September 16, 2016.
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.