FDA 483 - LEESAR, INC - October 29, 2021

An FDA inspection of LEESAR, INC., a 503B outsourcing facility in Fort Myers, FL, was conducted from October 18-29, 2021. The inspection revealed five observations.

Observation 1 noted a failure to thoroughly review unexplained discrepancies. Specifically, the firm failed to fully investigate out-of-specification (OOS) potency test results for Vancomycin 1.5g Lot (b)(4) (89.4% vs. (b)(4)%) and Vancomycin 1.25g Lot (b)(4) (89.8% vs. (b)(4)%), with both batches released without proper justification or investigation. Additionally, the firm failed to investigate compounding batch yield failures for Phenylephrine and Calcium Gluconate batches, which were released despite not meeting the ≥90% yield specification, and without potency testing.

Observation 2 indicated that written procedures for in-process material testing were not established, and the automated compounding system's consistency for potency had not been validated.

Observation 3 highlighted deficiencies in master production and control records, specifically the absence of final batch yield calculations and inaccurate visual inspection training pass/fail criteria that did not account for false positives, leading to an unqualified operator performing inspections.

Observation 4 stated that the outsourcing facility failed to submit a required report to FDA identifying all drugs compounded in the previous six-month period, specifically omitting