Eugia Pharma Specialities Limited
Form 483 issued February 6, 2026 · Sangareddy, India
- Inspection
- Jan 27 – Feb 6, 2026
- Investigators
- Lisa L. Flores· Patty P. Kaewussdangkul· Unnee Ranjan
- Observations
- 11
- Pages
- 29
- FEI number
- 3008461619
In short: On February 6, 2026, FDA issued a Form 483 with 11 observations to Eugia Pharma Specialities Limited in Sangareddy, India (FEI 3008461619) after an inspection that ran Jan 27 – Feb 6, 2026. The investigators were Lisa L. Flores, Patty P. Kaewussdangkul and Unnee Ranjan. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and quality system account for 7 of 11 observations.
Most cited: 21 CFR 211.113(b) (2×)
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 not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) 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 211.113(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 11 observations on this Form 483, mostly about laboratory controls, quality system and 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?
Lisa L. Flores, Patty P. Kaewussdangkul and Unnee Ranjan are named on this Form 483, for the inspection of Jan 27 – Feb 6, 2026. Each investigator has a profile showing what they cite most.
When was Eugia Pharma Specialities Limited inspected by FDA?
The inspection ran Jan 27 – Feb 6, 2026, and the Form 483 is dated February 6, 2026.
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.