EUGIA Pharma Specialities Limited
Form 483 issued November 14, 2025
- Inspection
- Nov 3 – Nov 14, 2025
- Investigator
- Angelica M. Hernandez
- Observations
- 9
- Pages
- 14
- FEI number
- 3009883410
In short: On November 14, 2025, FDA issued a Form 483 with 9 observations to EUGIA Pharma Specialities Limited (FEI 3009883410) after an inspection that ran Nov 3 – Nov 14, 2025. The investigator was Angelica M. Hernandez.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the Quality Unit are not fully followed Aseptic processing operations…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
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 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at EUGIA Pharma Specialities Limited?
FDA listed 9 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected EUGIA Pharma Specialities Limited?
Angelica M. Hernandez is named on this Form 483, for the inspection of Nov 3 – Nov 14, 2025. Each investigator has a profile showing what they cite most.
When was EUGIA Pharma Specialities Limited inspected by FDA?
The inspection ran Nov 3 – Nov 14, 2025, and the Form 483 is dated November 14, 2025.
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.