FDA EIR - Fernandez Development Co. - September 16, 2021

An FDA surveillance inspection of Fernandez Development Co., a dietary supplement manufacturer in Chatsworth, CA, occurred from September 8 to September 16, 2021. Conducted under the Compliance Program Guidance Manual for dietary supplements, the inspection revealed two significant issues. The company refused to make required records, including master manufacturing records, batch records, and product labeling for a specific lot of Aloe Vera Gel, available for inspection and copying as mandated by 21 CFR 111.610(a). Additionally, the firm failed to establish adequate product specifications for the identity, purity, strength, and composition of its finished dietary supplements, as required by 21 CFR 111.70(e). The provided specification for the Aloe Vera Gel was dated after its production and distribution and lacked essential details. Fernandez Development Co. received a Form FDA 483 outlining these observations and was reminded of its responsibility to comply with the Food, Drug, and Cosmetic Act. An adequate written response within 15 business days is required to avoid potential FDA follow-up actions.