FDA WARNING_LETTER - Nutri Spec Inc - April 24, 2014

The FDA conducted inspections at Nutri Spec, Inc.'s Mifflintown, PA facility (April 7-24, 2014) and Nutri Spec Testing's Indiana, PA facility (March 26-April 23, 2014). 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). Product labels also violated food labeling requirements (21 CFR Part 101), causing products to be misbranded under 21 U.S.C. § 343.

Mifflintown facility violations included: 1. Lack of production and process controls and specifications (21 CFR 111.55, 111.70). 2. Incomplete batch production records (BPRs) for products like "A Good Thyme" and "Magnesium Chloride" (21 CFR 111.255(b), 111.260). 3. Failure to implement quality control operations (21 CFR 111.65). 4. Absence of written Master Manufacturing Records (MMRs) for various products (21 CFR 111.205(a