FDA WARNING_LETTER - Nationwide Laboratories, LLC - November 27, 2018

The FDA inspected Nationwide Laboratories, LLC from October to November 2018, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm also introduced an unapproved new drug, salicylic acid 6% lotion, violating sections 505(a) and 301(d) of the FD&C Act, and this product was misbranded under section 502(f)(1). Key CGMP deficiencies included the failure to establish an adequate quality control unit (QU) with proper authority and procedures (211.22(a) and (d)), leading to inadequate oversight of contract manufacturing organizations (CMOs) and insufficient batch review and release processes. The firm also failed to establish and follow adequate written procedures for handling drug product complaints (211.198(a)), with a non-functional complaint line. These issues represent repeat violations from a 2016 inspection, indicating inadequate executive management oversight. The FDA recommends engaging a qualified CGMP consultant. Nationwide Laboratories must provide a comprehensive assessment with corrective and preventive actions (CAPA), including retrospective batch reviews, within 15 working days. Failure to correct these violations may result in legal action, including seizure, injunction, and withholding of drug application approvals.