Form FDA 483 · Issued 2026-02-27
Eugia Pharma Specialities Limited — FDA Form 483 Analysis
FEI: 3011960448 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Pharmaceutical Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Eugia Pharma Specialities Limited (FEI 3011960448) on 2026-02-27 following an inspection of its sterile pharmaceutical manufacturer operations in India. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.166(a)(2)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Stability sample storage conditions described
Inspector Observation Language: "The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, observed during inspection of Eugia Pharma Specialities Limited on 2026-02-27."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #2 · 21 CFR 211.188(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Accurate reproduction
Inspector Observation Language: "The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or control record] [checked for accuracy, dated, and signed]. Specifically, observed during inspection of Eugia Pharma Specialities Limited on 2026-02-27."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.