FDA WARNING_LETTER - Vida International, Inc. - December 13, 2018

The FDA inspected Vida International, Inc.'s drug manufacturing facility in Taiwan from December 10-13, 2018, uncovering significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), which renders their drug products adulterated. The firm's December 21, 2018, response was deemed inadequate. Key deficiencies included the failure to perform appropriate laboratory testing for drug product release, including identity and strength of active ingredients and microbial attributes (21 CFR 211.165(a) and (b)). The firm also failed to conduct identity and quality testing for incoming raw materials and components (21 CFR 211.84(d)(1) and (2)). Furthermore, an adequate quality control unit with proper authority was not established (21 CFR 211.22(a)), and batch production and control records lacked complete information (21 CFR 211.188). The firm acknowledged violations and stated it would cease shipping drugs to the U.S., but its response lacked a remediation timeline or details on distributed products. FDA placed the firm on Import Alert 66-40 on March 11, 2019. The FDA strongly recommended engaging a qualified CGMP consultant if the firm intends to resume U.S. market manufacturing. Failure to correct violations could lead to continued refusal of admission for products and withholding of new drug application approvals. A written response detailing corrective actions is required within 15 working days.