FDA WARNING_LETTER - Parrillo Performance Inc. - February 29, 2012

From February 13-29, 2012, the FDA inspected Parrillo Performance's dietary supplement manufacturing and re-packaging facility in Fairfield, Ohio, revealing significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). These violations render the firm's dietary supplement products adulterated under Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. Failure to establish component specifications for purity, strength, and composition (21 CFR 111.70(b)). 2. Failure to conduct identity testing for dietary ingredient components prior to use (21 CFR 111.75(a)(1)(i)). 3. Absence of written procedures for quality control operations, material review, disposition decisions, and reprocessing approval/rejection (21 CFR 111.103). 4. Failure to prepare and follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)). 5. Deficiencies in Batch Production Records (BPRs), lacking information on equipment identity, cleaning/sanitizing dates, unique identifiers for components/packaging/labels, documentation of finished product specifications, and proper documentation of manufacturing, packaging, and labeling operations, including initials of personnel and quality control approvals