Form FDA 483 · Issued 2026-04-17
Cliantha Research Limited — FDA Form 483 Analysis
FEI: 3017682080 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Regulated Products) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Cliantha Research Limited (FEI 3017682080) on 2026-04-17 following an inspection of its producer of regulated products operations in India. The report documents 2 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.25(a)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
GMP Training Frequency
Inspector Observation Language: "GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them. Specifically, observed during inspection of Cliantha Research Limited on 2026-04-17."
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(a)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Buildings of Suitable Size, Construction, Location
Inspector Observation Language: "Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations. Specifically, observed during inspection of Cliantha Research Limited on 2026-04-17."
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.