FDA WARNING_LETTER - Nutritional Engineering Inc - May 03, 2017

On September 29, 2017, the FDA issued a Warning Letter to Nutritional Engineering Inc. following an inspection from April 11 to May 3, 2017. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products like (b)(4) and (b)(4) adulterated. Additionally, products such as (b)(4), (b)(4), and (b)(4) were found to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act.

Key CGMP violations included failure to establish identity specifications for components (21 CFR 111.70(b)(1)), qualify suppliers by confirming certificate of analysis reliability (21 CFR 111.75(a)(2)(ii)(A)), and verify finished product specifications through testing (21 CFR 111.75(c)). The firm also used inappropriate and unconfirmed reference standards for testing (21 CFR 111.75(h)(1)), failed to establish controls in Master Manufacturing Records (MMRs) (21 CFR 111.205(b)(2)), and did not accurately follow MMRs in Batch Production Records (BPRs) (21 CFR 111.255(c)). Furthermore, the company