Form FDA 483 · Issued 2025-11-14
Eugia Pharma Specialities Limited — FDA Form 483 Analysis
FEI: 3011960448 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Product Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Eugia Pharma Specialities Limited (FEI 3011960448) on 2025-11-14 following an inspection of its sterile drug product manufacturer operations in India. The report documents 2 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.94(c)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Containers & Closures Clean, Sterilized, Pyrogen-free
Inspector Observation Language: "Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use. Specifically, observed during inspection of Eugia Pharma Specialities Limited on 2025-11-14."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #2 · 21 CFR 211.180(f)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Responsible firm officials notified in writing
Inspector Observation Language: "Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices]. Specifically, observed during inspection of Eugia Pharma Specialities Limited on 2025-11-14."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.