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# CGMP Violations at Korea’s Hanlim Pharm
- URL: https://www.fdaweb.com/cgmp-violations-at-koreas-hanlim-pharm/
- Published: 2018-10-16T12:00:00.000Z
- Updated: 2026-09-15T00:38:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142592

A 1/29-2/26 FDA inspection at Hanlim Pharm Co., Gyeonggi-do, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/3 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm622860.htm?ref=fdaweb.com) says the specific violations were: 

- failing to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
- failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards; and
- failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records.

The letter says Hanlim’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. The company was told to provide: **(1)** a comprehensive investigation into the extent of the inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; and **(3)** a management strategy for the firm that includes the details of its global corrective and preventive action plan.

FDA notes that the company has retained a CGMP consultant and says it strongly recommends that the consultant be qualified as described in regulations to assist the firm in meeting CGMP requirements. It also recommends a comprehensive audit of Hanlim’s entire operation for CGMP compliance and to evaluate the sufficiency and effectiveness of corrective and preventive actions before the company pursues resolution of its compliance status with FDA.

Hamlin was placed on an Import Alert 5/3\. The company was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.