FDA EIR - JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV - May 03, 2021

The FDA conducted a follow-up inspection of Johnson and Johnson Consumer Inc., Division of McNeil, Inc.'s Fort Washington, PA facility from April 21 to May 3, 2021. This inspection was mandated by a 2011 consent decree (injunction #11-1745) that followed previous compliance issues. The inspection was conducted under the Federal Food, Drug and Cosmetic Act, adhering to Compliance Programs 7356.002 and 7356.021 for drug manufacturing. No FDA-483 observations were issued during this inspection, indicating overall compliance with current good manufacturing practices.

Key discussions during the inspection included an investigation into a complaint regarding suspected Burkholderia cepacia complex transmission in Children’s Tylenol Suspension. Although the bacteria were found in a cleaning verification sample from a specific manufacturing system, no direct link to the product or cross-contamination was established. The firm implemented corrective actions, including chemical sanitization and equipment modification, and management was advised to maintain continuous monitoring for B. cepacia contamination. Furthermore, the inspection noted the firm's ongoing, phased implementation of Burkholderia cepacia complex testing for non-sterile products, as required by USP <60> since December 2019. The FDA emphasized the expectation for more rapid implementation across all relevant formula codes.