FDA WARNING_LETTER - King Bio Inc. - July 20, 2018

The FDA inspected King Bio, Inc. from July 9-20, 2018, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. FDA testing revealed inordinately high microbiological contamination in finished homeopathic drugs. Additionally, "Cold Sores & Herpes," "Adrenal Burnout," and "Lymph Detox" were deemed misbranded. Key CGMP violations included: 1) Failure to establish an adequate quality control unit (21 CFR 211.22(a)), evidenced by recurring out-of-limit microbial results in water and finished products, including opportunistic pathogens, and a lack of effective investigations or recalls until FDA intervention. 2) Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)), specifically lacking manufacturing process validation and adequate demonstration of antimicrobial effectiveness for preservative systems. 3) Failure to use appropriately designed equipment (21 CFR 211.63), as purified water systems had design flaws (e.g., dead-legs) leading to persistent microbial contamination. The misbranded drugs were classified as prescription drugs under section 503(b)(1)(A) of the FD&C Act but failed to bear the "Rx only" symbol, violating section 503(b)(4). The FDA strongly recommended engaging a qualified CGMP consultant. The firm recalled water-containing drugs and agreed to notify FDA before resuming manufacturing. King Bio must promptly correct all violations, provide detailed corrective action plans within 15 working days, or face potential legal action, including seizure and injunction.