FDA WARNING_LETTER - El-Gen LLC - January 31, 2012

On August 3, 2012, the FDA issued a Warning Letter to El-Gen LLC, a dietary supplement manufacturer, following an inspection from January 26-31, 2012. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplement products adulterated. Additionally, products like Rejeneril A, Cellvox Cell Energy, and Cell Power were found to be misbranded under 21 U.S.C. § 343 due to non-compliance with labeling regulations (21 CFR Part 101).

Key CGMP violations included failure to conduct identity testing for dietary ingredients (e.g., Vitamin A Acetate in Rejeneril lot #110911), failure to establish product specifications for dietary supplements (e.g., Rejeneril A), and inadequate written procedures and documentation for quality control operations, including material review, disposition decisions, and identification of qualified quality control personnel. The firm's February 13, 2012, response regarding these issues was deemed inadequate.

Misbranding violations included incorrect nutrition information on labels (e.g., missing Percent Daily Value for Molybdenum, incorrect order and nomenclature of ingredients, improper segregation of dietary ingredients, and missing heavy bars in the Supplement Facts panel). Furthermore, products were misbranded for failing to declare purified water as