Morning Star OTC, Inc. – FDA 483, Jul 10, 2025

An FDA inspection conducted on July 9-10, 2025, at Morning Star OTC, Inc., a repacker of human over-the-counter (OTC) drug products located in Los Angeles, CA, resulted in the issuance of a Form FDA 483. The primary observation noted during the inspection highlighted a significant deficiency within the firm's quality control unit. Specifically, the company was found to lack written procedures governing critical operational aspects.

The inspection revealed that Morning Star OTC, Inc. has not established written procedures for several essential functions, including the release of drug products to the market, the completion of batch records, and the recall of products from the market. This absence of documented processes indicates a non-conformance with regulatory expectations, particularly Good Manufacturing Practices (GMP), which mandate robust quality systems for drug product manufacturing and repacking. This is a critical observation under the Federal Food, Drug and Cosmetic Act.

An FDA Form 483 lists inspectional observations and is not a final determination of compliance. However, it signals areas requiring immediate attention. Morning Star OTC, Inc. is expected to respond to these observations by outlining corrective actions implemented or planned to address the identified procedural gaps. Prompt and effective remediation is necessary to ensure the quality, safety, and regulatory compliance of their OTC drug products.