FDA WARNING_LETTER - Accra-Pac, Inc. - September 02, 2022

The FDA inspected Accra-Pac, Inc. dba Voyant Beauty, a drug manufacturing facility in Elkhart, Indiana, from August 23 to September 2, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR parts 210 and 211, rendering drug products adulterated. FDA lab testing confirmed benzene contamination in a drug product, indicating a critical quality assurance failure. Key violations include the firm's failure to thoroughly investigate unexplained discrepancies or failures of batches to meet specifications (21 CFR 211.192), specifically regarding benzene contamination from propellants, with investigations deemed inadequate in scope and root cause analysis. The firm also failed to conduct appropriate microbiological testing for each batch of topical drug products (21 CFR 211.165(b)), despite being a contract manufacturer responsible for drug quality. Furthermore, the firm failed to adequately test incoming components, specifically for diethylene glycol (DEG) and ethylene glycol (EG) in glycerin (21 CFR 211.84(d)(1)), a critical safety concern. The FDA requires a written response within 15 working days detailing corrective actions, including comprehensive risk assessments, updated procedures, and verification against blending non-conforming materials. Failure to address these issues may result in further regulatory action, including seizure, injunction, and impact on product approvals and export certificates.