Form FDA 483 · Issued 2026-02-06
Eugia Pharma Specialities Limited — FDA Form 483 Analysis
FEI: 3011960448 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Eugia Pharma Specialities Limited (FEI 3011960448) on 2026-02-06 following an inspection of its sterile drug manufacturer operations in India. The report documents 5 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.28(a)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Clothing appropriate for duties performed
Inspector Observation Language: "Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not appropriate for the duties they perform. Specifically, observed during inspection of Eugia Pharma Specialities Limited on 2026-02-06."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #2 · 21 CFR 211.42(c)(10)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Aseptic Processing Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. Specifically,observed during inspection of Eugia Pharma Specialities Limited on 2026-02-06."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #3 · 21 CFR 211.130(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Prevention of cross contamination, mix-ups
Inspector Observation Language: "There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination. Specifically, observed during inspection of Eugia Pharma Specialities Limited on 2026-02-06."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #4 · 21 CFR 211.180(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Record maintenance 1 year (except exempt OTC)
Inspector Observation Language: "All records of [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product were not maintained at least one (1) year after the expiration date. Specifically, observed during inspection of Eugia Pharma Specialities Limited on 2026-02-06."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #5 · 21 CFR 211.186(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Signature and checking of records -- 2 persons
Inspector Observation Language: "The master production and control records for each batch size of drug product are not [prepared, dated, and signed by one person with a full handwritten signature] [independently checked, dated, and signed by a second person]. Specifically, observed during inspection of Eugia Pharma Specialities Limited on 2026-02-06."
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.