FDA WARNING_LETTER - McDaniel Life-Line LLC - November 16, 2018

The FDA inspected McDaniel Life-Line LLC's drug manufacturing facility from November 6-16, 2018, and reviewed their websites, identifying significant violations. The product "Indian Herb" is deemed an unapproved new drug under section 505(a) and a misbranded drug under section 502 of the FD&C Act. It is also adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) due to insanitary conditions and non-conformance to CGMP regulations (21 CFR, parts 210 and 211).

"Indian Herb" is marketed as a dietary supplement but is a drug due to claims of treating diseases and affecting body structure/function, such as balancing metabolism, treating abnormal growths, and killing viruses. It is also an unapproved new drug as it's not generally recognized as safe and effective. The product is misbranded because it lacks adequate directions for use by a layperson, as it's intended for conditions requiring professional supervision.

CGMP violations include manufacturing in a residential kitchen with household utensils, inadequate water system (unfiltered, unmonitored, corroded tanks with microbial growth including *Pseudomonas aeruginosa*), lack of separate/defined areas to prevent contamination, absence of a quality control unit, failure to investigate a serious customer complaint (necrosis of the nose), lack of release testing for