FDA 483 - LEESAR, INC - May 09, 2025

An FDA inspection of LEESAR, INC., a 503B Outsourcing Facility in Fort Myers, FL (FEI 3010166880), was conducted from April 29, 2025, to May 9, 2025. The inspection identified four observations.

Observation 1, a repeat from a 2021 inspection, cited the firm for failing to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, an OOS pH result for Azithromycin 500mg in Dextrose 5% IV Bag (Lot# <Redacted B4> and <Redacted B4>) was not fully investigated prior to release and distribution. The contract laboratory initially reported a pH of 7.2, outside the established range. Although retested to 7.0, a different specification range was used, which the firm's quality unit was unaware of. The investigation was incomplete, yet the product was released and distributed.

Observation 2 noted that the responsibilities and procedures of the quality control unit were not fully followed. The quality unit failed to properly classify deviations (e.g., OOS air samples, OOS potency for Oxytocin) as per their written procedure 6-8 rev 03, "Quality Events and Investigations Management Process." Additionally, procedure 6-27 rev 01, "Quality