FDA 483 - EO Products, LLC - October 23, 2025

EO Products, LLC, located in San Rafael, CA, underwent an FDA inspection from October 20 to October 23, 2025. The inspection revealed significant compliance issues primarily within the company's quality and laboratory systems. Key violations included the failure to adhere to established quality control procedures, particularly in investigating out-of-specification (OOS) results, deviations, and customer complaints. The firm did not follow its SOP-OAU-005 Quality Investigation Procedure, failing to determine root causes or implement corrective actions for OOS results. Additionally, EO Products did not conduct thorough investigations into customer complaints, notably those related to product scent issues.

The inspection also highlighted deficiencies in vendor qualification and reliance on unverified third-party laboratory results for active pharmaceutical ingredients and excipients. The firm neglected to perform necessary tests for high-risk drug components, indicating a lack of awareness of current Good Manufacturing Practice (cGMP) requirements.

Moreover, the suitability of testing methods was not verified under actual conditions of use, and the firm used an unvalidated method (SOP-QCU-099D) for raw material identification, which could compromise product quality.

EO Products is required to address these issues by conducting comprehensive investigations into OOS results and customer complaints, validating testing methods, and ensuring compliance with cGMP standards. Immediate corrective actions and preventive measures must be implemented to rectify these deficiencies and prevent recurrence. The firm is advised to engage with the FDA to discuss objections or corrective actions taken in response to these observations.