Newsletter - October 19, 2023
FDA Warning Letter to an Online Illegal Ozempic Seller
Earlier this month, the FDA issued a Warning Letter to an online pharmacy selling a generic version of GLP-1 analog, semaglutide, and in the process highlighted the limitations of such FDA actions for online pharmacies selling illegal products. So long as the consumers are willing to risk buying...Read More
Can the FDA Direct You to Hire a Consultant?
Last week, the FDA directed a South Korean drug manufacturer to hire a consultant to help with numerous non-compliance observations during an audit of their manufacturing facilities in South Korea. Such “suggestions” to audited parties to hire external experts are occasionally made in Warning Letters. Read More
FDA Warning Letter to an Online Illegal Ozempic Seller
Earlier this month, the FDA issued a Warning Letter to an online pharmacy selling a generic version of GLP-1 analog, semaglutide, and in the process highlighted the limitations of such FDA actions for online pharmacies selling illegal products. So long as the consumers are willing to risk buying...Read More
Can the FDA Direct You to Hire a Consultant?
Last week, the FDA directed a South Korean drug manufacturer to hire a consultant to help with numerous non-compliance observations during an audit of their manufacturing facilities in South Korea. Such “suggestions” to audited parties to hire external experts are occasionally made in Warning Letters. Read More
