H & L Jerch Sales, Inc. – FDA Warning Letter, Mar 14, 2012

On July 19, 2012, the FDA issued a Warning Letter to H & L Jerch Sales, Inc., DBA Bell Lifestyle Products, Inc., following an inspection from February 14 to March 14, 2012. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. Failure to establish and maintain written procedures for quality control operations, including material review, disposition decisions, and reprocessing approval (21 CFR 111.103, 111.140(b)(1)). The firm also failed to keep required records for quality control activities and identify qualified personnel for quality control (21 CFR 111.140(b)(2), 111.140(b)(3), 111.12(b)). 2. Failure to establish and follow written procedures for handling returned dietary supplements (21 CFR 111.503) and maintain associated records (21 CFR 111.535(b)). 3. Failure to establish and follow written procedures for reviewing and investigating product complaints (21 CFR 111.