FDA 483 - Orly International, Inc. - December 20, 2022

An FDA inspection conducted at Orly International, Inc., from December 12 to December 20, 2022, revealed significant compliance deficiencies concerning the manufacture of over-the-counter (OTC) drug products, particularly hand sanitizers. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act, highlighted multiple areas requiring immediate corrective action to adhere to Current Good Manufacturing Practices (cGMP).

Key observations included unsupported expiration dates for hand sanitizers, where products were relabeled with extended shelf lives without adequate stability data. The firm’s stability program itself was found to be deficient, lacking comprehensive studies, essential testing like assay and microbiological analysis, and proper control of environmental conditions for stability samples. Additionally, time limits for holding in-process bulk hand sanitizer were not established, and the quality of long-stored bulk product was not adequately assessed before use.

Further issues involved the firm's water system, which was unvalidated and had insufficient routine monitoring. Equipment used in drug manufacturing was not qualified, and cleaning and maintenance procedures lacked proper validation, including risk assessments for cross-contamination. The quality control unit exhibited shortcomings, such as failing to qualify contract manufacturers, conduct annual product reviews, and maintain retain samples. Finally, employees were not provided with current Good Manufacturing Practices training. Orly International, Inc. is required to address these observations to ensure product quality and regulatory compliance.