Eugia Pharma Specialities Limited
Form 483 issued April 28, 2017 · Medak District, India
- Inspection
- Apr 20 – Apr 28, 2017
- Investigators
- Saleem A. Akhtar· Scott Ballard
- Observations
- 1
- Pages
- 9
- FEI number
- 3008461619
In short: On April 28, 2017, FDA issued a Form 483 with 1 observation to Eugia Pharma Specialities Limited in Medak District, India (FEI 3008461619) after an inspection that ran Apr 20 – Apr 28, 2017. The investigators were Saleem A. Akhtar and Scott Ballard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.58 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacturing of a drug product are not maintained in a…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.58
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 facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Eugia Pharma Specialities Limited?
Saleem A. Akhtar and Scott Ballard are named on this Form 483, for the inspection of Apr 20 – Apr 28, 2017. Each investigator has a profile showing what they cite most.
When was Eugia Pharma Specialities Limited inspected by FDA?
The inspection ran Apr 20 – Apr 28, 2017, and the Form 483 is dated April 28, 2017.
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.