FDA 483 - June Jacobs Labs, LLC - November 04, 2024

An FDA inspection of June Jacobs Labs, LLC, located in Moonachie, NJ, was conducted from October 23 to November 4, 2024. The inspection revealed several significant observations indicating potential non-compliance with current Good Manufacturing Practices (cGMP), as referenced under the Federal Food, Drug and Cosmetic Act. Key issues revolved around the firm's quality control processes for drug products, specifically concerning Max Mineral SPF 45, lot# 23C132.

The main violations included a lack of written records for investigations into batch failures; for instance, the aforementioned product failed its viscosity specification but no investigation was documented. Furthermore, labeling and packaging materials were not adequately sampled, examined, or approved by the quality unit before being used for this product lot. Most critically, the company released Max Mineral Tinted Sunscreen SPF 45 lot 23C132 for distribution despite laboratory test results indicating it failed to meet viscosity specifications. These observations highlight deficiencies in the company's quality system related to failure investigations, material control, and final product release. June Jacobs Labs, LLC is expected to address these findings with comprehensive corrective actions to ensure adherence to regulatory standards for drug product manufacturing.