FDA WARNING_LETTER - Nutri Spec Testing - April 24, 2014

The FDA issued a Warning Letter to Nutri Spec, Inc. following inspections of their Mifflintown, PA (April 7-24, 2014) and Indiana, PA (March 26-April 23, 2014) facilities. Both facilities were found to have serious violations of Current Good Manufacturing Practice (cGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under 21 U.S.C. § 342(g)(1). Additionally, product labels were found to violate food labeling requirements (21 U.S.C. § 343 and 21 CFR Part 101).

Key violations at the Mifflintown facility included: * Failure to implement a system of production and process controls and provide specifications (21 CFR 111.55, 111.70). * Incomplete Batch Production Records (BPRs) lacking essential information like equipment identity, cleaning dates, component weights, yield statements, and quality control documentation (21 CFR 111.255(b), 111.260). * Failure to implement quality control operations (21 CFR 111.65). * Absence of written Master Manufacturing Records (MMRs) for various products (21 CFR