FDA 483 - Lupin Research Inc - February 19, 2020

Lupin Research Inc. in Coral Springs, FL, was cited with two observations during an FDA inspection of its inhalation drug product manufacturing. The firm's batch production and control records were found to be incomplete, lacking essential documentation for critical process parameters and product information. Additionally, the quality control unit failed to adequately review the completeness of executed batch production records for validation batches.