US Compounding Inc – FDA 483, Feb 7, 2019

This FDA Form 483, issued to an unnamed pharmaceutical compounding facility following a recent inspection (observations from 2018-2019), details ten significant observations regarding deviations from current Good Manufacturing Practices (GMP). Key violations span several critical areas, many of which are repeat observations from prior inspections (2015, 2016).

Environmental monitoring in aseptic processing areas was found deficient (Observation 1, repeated). The firm failed to investigate numerous mold recoveries, conduct required surface sampling, and justify reduced monitoring frequencies despite concerning mold trends. Relatedly, cleaning and disinfection procedures were inadequate (Observation 2), lacking validation and failing to prevent cross-contamination or address out-of-specification events. Infrastructure was also cited for non-cleanroom grade ceiling sealants (Observation 3).

Significant issues were identified in procedures designed to prevent microbiological contamination (Observation 4). Media fills did not simulate challenging conditions, and dynamic airflow studies were absent for an extended period, revealing turbulent air patterns. The validation of aseptic and sterilization processes was also absent (Observation 5).

The quality system exhibited severe deficiencies (Observation 6, repeated). The company failed to thoroughly investigate unexplained discrepancies and out-of-specification results, including consumer complaints of particulate matter (identified as fungus/mold) in distributed sterile morphine. Supplier control was weak, with reliance on Certificates of Analysis without adequate in-house testing or quality agreements (Observation 8). The Quality Control unit lacked appropriate authority for component and product release (Observation 9, repeated). Finally, numerous drug product labels were found deficient, missing critical information such as inactive ingredients, dosage forms, required statements like "compounded drug," and storage instructions (Observation 10). The company must implement comprehensive corrective actions to address these systemic failures and ensure product quality and patient safety.