FDA WARNING_LETTER - Herbal Doctor Remedies - April 19, 2019

On October 4, 2019, the FDA issued a Warning Letter to Herbal Doctor Remedies following an inspection from April 15-19, 2019, at their Monterey Park, CA facility. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(A) and (B) due to insanitary conditions and non-conformity to CGMP.

Specific violations included: - **Insanitary Conditions:** Observation of layers of brown dust-like residue throughout manufacturing areas and equipment, with the main manufacturing area opening to the outside. - **CGMP Violations:** 1. Failure to establish an adequate quality unit with procedures for roles, responsibilities, deviation investigations, complaint handling, component identity testing, supplier qualification, and final product release testing (21 CFR 211.22, 211.84, 211.165(a), 211.130). 2. Failure to establish a system for drug product distribution to facilitate recalls (21 CFR 211.150(b)). 3. Failure to clean and maintain equipment and utensils at appropriate intervals, and lack of written cleaning procedures (21 CFR 211.67(a) & (b)).