FDA WARNING_LETTER - God's Garden Pharmacy - January 20, 2011

On January 14, 18, and 20, 2011, the FDA inspected God's Garden Pharmacy in San Diego, California, a manufacturer of dietary supplements. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111), rendering the firm's products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. Key CGMP deficiencies included the failure to prepare and follow written Master Manufacturing Records (21 CFR 111.205(a)) and Batch Production Records (21 CFR 111.255(a)). The firm also lacked written procedures for quality control operations (21 CFR 111.103) and records for cleaning and pest control (21 CFR 111.23(b)). Additionally, hand-washing facilities were inadequate, lacking hot water (21 CFR 111.15(i)). Beyond CGMP issues, several products, including Quick Action Slim Tea, Prostate Comfort, Cholesterol Tea, and Diabetina Sugar Balance Tea, were found to be misbranded under Section 403 of the Act, due to issues such as missing 'Supplement Facts' panels, incorrect nutrient declarations, and failure to identify plant parts for ingredients. The firm's initial response was deemed inadequate due to a lack of documentation for corrective actions. God's Garden Pharmacy is required to provide a written response within 15 working days detailing specific steps taken to correct these violations, with supporting documentation, to avoid potential enforcement actions like product seizure or injunction.