FDA WARNING_LETTER - Diamond Wipes International, Inc. - May 17, 2017

The FDA inspected Diamond Wipes International Inc. from May 8-17, 2017, identifying significant Current Good Manufacturing Practice (CGMP) violations that render their finished drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies include the firm's failure to establish adequate production and process controls (21 CFR 211.100(a)), specifically concerning a non-validated water system that consistently produced microbiologically contaminated water, including potentially pathogenic gram-negative bacteria, used in topical drug products. The firm also failed to thoroughly investigate unexplained discrepancies or out-of-specification (OOS) results (21 CFR 211.192), releasing products with fungal levels exceeding specifications without proper investigation. Furthermore, a repeat observation highlighted the firm's failure to establish an adequate quality control unit (21 CFR 211.22(a)) with the authority to approve products before distribution, as lots were released prior to complete analytical testing and QCU approval. The FDA recommended engaging a CGMP consultant and noted the firm's role as a contract manufacturer, emphasizing their responsibility for compliance and informing clients of quality issues. The letter requires comprehensive corrective and preventive actions, including water system remediation, OOS investigation improvements, QCU strengthening, and a risk assessment of distributed products, with a 15-working-day response. Failure to comply may result in legal action, including seizure, injunction, and impact on drug application approvals and export certificates.