Eugia Pharma Specialities Limited
Form 483 issued February 20, 2018 · Medak District, India
- Inspection
- Feb 12 – Feb 20, 2018
- Investigator
- Yasamin Ameri
- Observations
- 2
- Pages
- 6
- FEI number
- 3008461619
In short: On February 20, 2018, FDA issued a Form 483 with 2 observations to Eugia Pharma Specialities Limited in Medak District, India (FEI 3008461619) after an inspection that ran Feb 12 – Feb 20, 2018. The investigator was Yasamin Ameri. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.67
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 facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Eugia Pharma Specialities Limited?
Yasamin Ameri is named on this Form 483, for the inspection of Feb 12 – Feb 20, 2018. Each investigator has a profile showing what they cite most.
When was Eugia Pharma Specialities Limited inspected by FDA?
The inspection ran Feb 12 – Feb 20, 2018, and the Form 483 is dated February 20, 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.