Customceutical Compounding – FDA Warning Letter, Mar 8, 2019

On August 25, 2020, the FDA issued a Warning Letter to Customceutical Compounding, LLC, following an inspection from February 27 to March 8, 2019. The inspection revealed serious deficiencies in sterile drug product production, leading to adulterated drug products under FDCA Section 501(a)(2)(A) due to insanitary conditions.

Key violations included: - Poor aseptic processing practices, such as failure to sanitize materials and personnel exposing facial skin in ISO 5 areas. - Inadequate product evaluation and remedial action after microbial contamination on a technician's glove. - Failure to perform adequate smoke studies under dynamic conditions for unidirectional airflow in ISO 5 areas. - Use of non-sterile cleaning wipes in the ISO 5 area. - Inadequate sanitization of equipment and insufficient disinfectant contact time. - Improper gowning procedures, allowing apparel to touch the floor. - Inadequate containment and cleaning for hazardous drug products, leading to potential cross-contamination.

The firm ceased sterile compounding on March 29, 2019, and initiated a voluntary recall of sterile injectables and solutions on April 8, 2019. The FDA found the firm's corrective action response regarding cross-contamination inadequate due to insufficient documentation (e.g., lack of detailed SOPs, training records, and audit documentation).

The FDA strongly recommends a comprehensive