FDA Warns Chinese OTC Drug Manufacturer Following Review of Records

On 07 November 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese company registered as a manufacturer of over-the-counter (OTC) drug products in the United States. This action followed a review of the company’s records, which revealed significant violations of Current Good Manufacturing Practices (CGMP).

The violations include:

• Quality control unit failures: The company’s quality control unit failed to ensure that its drug products met established specifications for identity, strength, quality, and purity. Notably, the firm produced isopropyl alcohol prep pads labeled as sterile without demonstrating that the manufacturing processes rendered the products sterile.
• Inadequate laboratory testing for the drug product: The firm did not conduct the necessary laboratory testing to verify that each batch of drug products met final specifications, including the identity and strength of active ingredients, before release.
• Identity testing of incoming components: The authority writes that the firm did not perform diethylene glycol/ethylene glycol limit testing for the glycerin and propylene glycol components, or methanol limit testing for your ethanol and isopropyl alcohol components.

Due to these CGMP violations, the FDA considers the company’s drug products to be adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The agency has urged the firm to take immediate corrective actions to address these deficiencies and comply with CGMP regulations. The authority recommends the company engage a qualified consultant to evaluate its operations and provide guidance on meeting CGMP requirements.

The complete Warning Letter to Zhejiang Qimei Cosmetics Co., Ltd. is available on the FDA's website.