Warning letter to South Korea - from process validation to analysis of starting and raw materials

The US Food and Drug Administration (FDA) recently issued a Warning Letter to FirstCham Co, Ltd. due to significant violations of Current GMP guidelines. The agency identified a number of deficiencies during an inspection of the company's drug production facility from 23 to 27 October 2023. In summary, the Warning Letter contains the following findings.

CGMP violations

The company did not perform tests to verify the identity of each component of one of your drug products and also failed to verify or, validate the reliability of supplier analyses at appropriate intervals. Particularly critical is the lack of the necessary tests for raw materials such as glycerine, which must be tested for contamination with diethylene glycol (DEG) and ethylene glycol (EG). FirstChem thus joins the list of companies that have been reprimanded in the recent past for failing to test for EG and DEG.

Deficiencies in the laboratory

Also inadequate was the documentation in the company's laboratory, These records did not contain all the necessary data to ensure compliance with established specifications and standards. There was a lack of information on the test methods used and the results compared to the defined specifications.

Production and process control procedures

In addition, there was no evidence that the manufacturing processes were properly validated to ensure that the medicinal products were consistently of the desired quality and purity. There was also a lack of adequate validation of the water system used to manufacture the products.

Quality control

The company's quality control function did not adequately fulfil its responsibilities to ensure that the medicinal products manufactured met CGMP standards. There were numerous deficiencies, including lack of procedures for process validation, equipment qualification and supplier qualification.

Misleading labelling

The product "Soo'Ae Hand Sanitising Wipes" was misleadingly labelled because the labelling gave the appearance of being approved or endorsed by the FDA, which was not the case. The labelling and advertising of the product as "FDA registered" and the presentation similar to the FDA logo on the product website were criticised as misleading.

As part of the Warning Letter, the FDA is requiring the company to take extensive corrective and preventive actions, including a detailed risk assessment for products that may contain ingredients contaminated with DEG or EG, a comprehensive review and validation of manufacturing processes and water systems, and a comprehensive review of quality assurance and documentation practices.

FirstCham Co., Ltd. has been placed on Import Alert 66-40 for these deficiencies, which means that company products imported into the U.S. that appear to be adulterated or mislabelled may be detained or denied importation until the company demonstrates compliance with CGMPs.

Further information can be found directly in the Warning Letter. The revised ECA webinar "Ethylene and Diethylene Glycol Testing" with a speaker from the United States Pharmacopoeia offers the opportunity to learn more about the current regulatory activities surrounding the frequent deficiencies in the area of ethylene and diethylene glycol testing.