FDA 483 - Choice All Natural, Inc. dba Om Botanical - December 02, 2022

An FDA inspection of Meds IV, a 503B Outsourcing Facility in Maumee, OH, conducted from November 14 to December 2, 2022, identified significant deficiencies in its manufacturing processes for sterile drug products. The observations, detailed in an FDA Form 483, indicate a lack of adherence to quality standards.

Key issues included the inadequate validation of sterilization processes, specifically regarding smoke studies and media fills that did not simulate challenging production conditions such as duration, batch size, or container volume. Personnel clothing was deemed inappropriate, with exposed skin observed during aseptic manipulations. The firm's environmental monitoring program was deficient, failing to conduct daily dynamic monitoring, establish appropriate alert/action levels, or use sporicidal agents. Furthermore, cleaning and disinfection procedures were ineffective, lacking proper disinfectant contact times and sporicidal agents for material transfer.

Meds IV also failed to perform endotoxin testing on each batch of sterile drug product and lacked a robust written stability program to establish and support appropriate expiration dates, resulting in unsupported beyond-use dates and sub-potent products. Notably, several of these violations were repeat observations from previous inspections in 2017 and 2020, signaling persistent non-compliance. Meds IV is required to implement comprehensive corrective actions to address these critical deficiencies and ensure compliance with manufacturing quality standards for sterile drug products.