Y. S. Health Corp. – FDA Warning Letter, Jan 30, 2013

The FDA issued a Warning Letter to Y.S. Health Corp. following an inspection from December 6, 2012, to January 30, 2013, revealing serious violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated. Additionally, product labeling and website review identified certain products as unapproved and/or misbranded drugs.

Specifically, "Arth 2000+ Cream," "HiBee Heart'n Brain Ultimate Omega-3," and "Arth 2000+ For Joint Flexibility & Pain Relief (180 capsules)" were deemed unapproved new drugs due to therapeutic claims (e.g., "Reduces Pain," "Helps Inflammation," "repairs damaged joints") and inclusion of unapproved active ingredients like "Kre-Celazine." These products also lacked adequate directions for layperson use, making them misbranded drugs.

CGMP violations included failure to: establish and follow written procedures for quality control operations (21 CFR 111.103, 111.140(b)(1)), prepare and follow adequate master manufacturing records (21 CFR 111.205(a)), maintain written records for packaging and labeling operations (21 CFR 111.180(b)(3)(i)), establish specifications for incoming materials (21 CFR