FDA 483 - Savings Distributors LLC - December 19, 2024

Savings Distributors LLC, a drug repackaging facility in Islandia, NY, underwent an FDA inspection from December 16-19, 2024. The inspection revealed significant deviations from regulatory expectations, primarily concerning quality control and production processes. Key observations included the quality control unit's failure to adhere to its own written procedures. Specifically, the firm lacked documented evidence for ongoing equipment calibration and maintenance, regular evaluations of Standard Operating Procedures (SOPs), and consistent reviews of training methods and components. Additionally, the company failed to perform required annual product reviews for its repackaged drug products.

A second major issue identified was the absence of established written procedures for production and process controls. The firm had not conducted packaging process validation or created specific written procedures for using critical repackaging equipment, including machinery involved with sterile ophthalmic products. Furthermore, there was no documented equipment qualification or calibration program for this essential equipment.

These observations indicate non-compliance with current Good Manufacturing Practices (cGMP) for drug repackagers, as outlined under the Federal Food, Drug, and Cosmetic Act. Savings Distributors LLC is expected to develop and implement thorough corrective actions to address these findings and ensure full adherence to regulatory requirements.