Warning Letter — Hanlim Pharm Co., Ltd.
The FDA issued a Warning Letter to Hanlim Pharm Co., Ltd. following an inspection by the Center for Drug Evaluation and Research (CDER). The letter identifies significant deviations from current good manufacturing practice (CGMP) regulations.
This affects Hanlim Pharm Co., Ltd., their internal quality and manufacturing departments, and any downstream supply chain partners relying on their pharmaceutical products.
A Warning Letter from CDER typically indicates that the FDA found facility conditions or manufacturing processes to be non-compliant with statutory requirements. This represents an escalation of enforcement that could lead to import alerts or the withholding of new drug approvals if the cited deficiencies are not remediated to the agency's satisfaction. The specific nature of the violations is not detailed in the excerpt, but the issuance itself signifies a breakdown in the quality control unit's oversight.
Conduct a thorough audit of site-specific manufacturing protocols and quality management systems to ensure alignment with CGMP standards. Review documentation practices and facility maintenance schedules to identify potential gaps that could trigger regulatory findings during inspections.
FDA Warning Letter issued to: Hanlim Pharm Co., Ltd.. 10/02/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hanlim-pharm-co-ltd-734782-10022026
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