FDA 483 - McNeil Healthcare, LLC - September 20, 2023

An FDA inspection of McNeil Healthcare, LLC in Las Piedras, PR, revealed five significant observations primarily related to quality control unit deficiencies and data integrity issues. The firm failed to thoroughly investigate discrepancies, including instances of password sharing and backdating, and did not submit required Field Alert Reports for out-of-specification excipients used in distributed drug products. Additionally, the inspection cited failures in following written production and complaint handling procedures, with one observation being a repeat from a previous inspection.