Article Summary:
The U.S. Food and Drug Administration (FDA) has issued warning letters to several drugmakers for various violations. Canadian OTC drugmaker Everlaan Organics and Chinese OTC drugmaker Anhui Hanbon Daily Chemical were cited for current good manufacturing practice (CGMP) violations. Everlaan failed to provide evidence that it tests final products to ensure they meet specifications, while Anhui Hanbon did not properly test incoming drug components for identity and contamination. Both companies lacked adequate stability testing programs.
The FDA also cited Everlaan for marketing unapproved drug products, including its Maple Organics Joint Therapy, Muscle Pain Relief, and Cough & Cold Relief lines. The agency stated these products are not generally recognized as safe and effective and do not meet OTC monograph requirements. Additionally, the FDA warned the website www.usaquickmeds.com for selling unapproved opioid and benzodiazepine products, noting the public health risks associated with the illicit sale of these controlled substances online.
Separately, the FDA issued a warning letter to medical device manufacturer Les Encres for quality system violations. The company failed to properly evaluate suppliers, implement corrective and preventive actions, and maintain procedures to ensure its absorbable polydioxanone surgical suture devices conform to requirements. The FDA also cited Les Encres for making unsupported marketing claims about its products being used for facial lifting and tightening treatments.
The FDA emphasized the importance of adhering to CGMP, marketing approved products, and properly reporting and addressing medical device issues. The agency warned that failure to address the violations could result in further regulatory action.