Form FDA 483 · Issued 2026-04-24
Jiangsu Hansoh Pharmaceutical Group Co Ltd. — FDA Form 483 Analysis
FEI: 3008316144 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Jiangsu Hansoh Pharmaceutical Group Co Ltd. (FEI 3008316144) on 2026-04-24 following an inspection of its sterile drug manufacturer operations in China. The report documents 3 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Personnel GMP Training, Gowning & Hygienic Practices.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.198(a)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Complaint Handling Procedure
Inspector Observation Language: "Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed]. Specifically, observed during inspection of Jiangsu Hansoh Pharmaceutical Group Co Ltd. on 2026-04-24."
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.
Observation #2 · 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 Jiangsu Hansoh Pharmaceutical Group Co Ltd. on 2026-04-24."
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 #3 · 21 CFR 211.42(a)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
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 Jiangsu Hansoh Pharmaceutical Group Co Ltd. on 2026-04-24."
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.