FDA WARNING_LETTER - Engineering Nutrition - December 20, 2013

The FDA conducted an inspection of Engineering Nutrition's dietary supplement manufacturing facility in Oceanside, CA, from December 10-20, 2013. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering the firm's dietary supplement products adulterated under the Federal Food, Drug, and Cosmetic Act. Additionally, product labeling was found to be misbranded under 21 CFR Part 101.

Key CGMP violations included the failure to establish required specifications for manufacturing processes (21 CFR 111.70(a)), confirm the identity of non-dietary ingredient components (21 CFR 111.75(a)(2)), and prepare and follow written master manufacturing records (21 CFR 111.205). The firm also failed to establish written procedures for quality control operations (21 CFR 111.103), product complaints (21 CFR 111.553), holding/distributing (21 CFR 111.453), and packaging/labeling operations (21 CFR 111.403). Furthermore, batch production records lacked complete information, specifically actual and theoretical yields (21 CFR 111.255(b), 111.260). The misbranding violation stemmed from not listing capsule ingredients on product labels (21 CFR 101.4(g)).

The firm's December 30, 2013, response to the FDA 483 was deemed inadequate for all violations, lacking sufficient detail, supporting documentation, and timelines for corrective actions. Engineering Nutrition must promptly correct all violations to prevent potential enforcement actions like seizure or injunction. A detailed written response outlining specific corrective actions and timelines is required within 15 working days, with the possibility of reinspection fees.