FDA WARNING_LETTER - AN Co. Ltd. - May 30, 2017

The FDA inspected AN Co. Ltd.'s drug manufacturing facility in Korea from May 29-30, 2017, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, the firm's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act. Key violations include the failure to thoroughly investigate out-of-specification (OOS) results (21 CFR 211.192), as demonstrated by an uninvestigated OOS viscosity result. The firm also failed to follow an adequate written stability testing program (21 CFR 211.166(a)), specifically by not testing products in their actual packaging and lacking assay for active ingredient in stability protocols. Furthermore, AN Co. Ltd. failed to establish and follow adequate control procedures for process validation (21 CFR 211.110(a)), with no process performance qualification studies or ongoing monitoring. The FDA found the firm's responses deficient and requested detailed OOS procedures, stability protocol revisions, process validation timelines and protocols, and a risk assessment for unvalidated products. The letter strongly recommends engaging a CGMP consultant. Failure to correct these violations could result in the FDA withholding new application approvals and refusing admission of products into the U.S. The firm must respond within 15 working days outlining corrective actions and a completion schedule.