EUGIA Pharma Specialities Limited
Form 483 issued February 27, 2026 · Medchal-Malkajgiri District, India
- Inspection
- Feb 16 – Feb 27, 2026
- Investigators
- Joseph A. Piechocki· Matthew B. Casale
- Observations
- 4
- Pages
- 6
- FEI number
- 3011960448
In short: On February 27, 2026, FDA issued a Form 483 with 4 observations to EUGIA Pharma Specialities Limited in Medchal-Malkajgiri District, India (FEI 3011960448) after an inspection that ran Feb 16 – Feb 27, 2026. The investigators were Joseph A. Piechocki and Matthew B. Casale. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmEUGIA Pharma Specialities Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at EUGIA Pharma Specialities Limited?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. 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?
Joseph A. Piechocki and Matthew B. Casale are named on this Form 483, for the inspection of Feb 16 – Feb 27, 2026. Each investigator has a profile showing what they cite most.
When was EUGIA Pharma Specialities Limited inspected by FDA?
The inspection ran Feb 16 – Feb 27, 2026, and the Form 483 is dated February 27, 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.