FDA Warning Letter for South Korean Manufacturer: Identity Testing, QU Oversight, Equipment Qualification and Maintenance

The U.S. Food and Drug Administration (FDA) has sent a new Warning Letter dated 04 October 2023 to a manufacturer located in South Korea.

The firm manufactures over-the-counter (OTC) topical drug products, such as hand sanitizers. The Warning Letter goes back to an inspection performed at the drug manufacturing facility in March 2023.

Key Findings

During the inspection, the FDA investigators observed specific CGMP violations in the following areas:

• Identity testing: According to the FDA, the company failed to adequately test the incoming components for identity. The company also relied on the suppliers’ certificates of analysis (COA) without establishing the reliability of the suppliers’ test analyses at appropriate intervals. This concerns in particular the ethanol component.
• Quality Unit (QU): The QU did not effectively exercise its responsibilities to oversee the quality of the drug manufacturing operations. The firm could not provide evidence that procedures were in place to provide the QU with the responsibility and authority to handle critical quality oversight operations.
• Annual product quality review (APQR): APQRs for the ethanol-based hand sanitizer drug products could not be provided.
• Equipment: There was no evidence of equipment qualification, maintenance, or calibration in production.
• Water System: Validation documents for the water system could not be provided.
• Gas chromatograph: There was no evidence that the gas chromatograph used for ethanol assay determination had been calibrated or had undergone routine maintenance within the last two years.

In addition, unapproved new drug and misbranding violations are mentioned in the Warning Letter.

The FDA already placed the firm on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs") on 24 July 2023. Based upon the nature of the violations, the FDA strongly recommends engaging a consultant to assist in meeting CGMP requirements.

For further information, please see the complete Warning Letter to Handock Cosmetics Co., Ltd. on the FDA website.