Health Technology Inc. – FDA Warning Letter, May 16, 2012

From May 8-16, 2012, the FDA inspected a dietary supplement manufacturing facility in Dawson, Georgia, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111) and dietary supplement labeling requirements. These violations render the firm's dietary supplements adulterated and misbranded.

Key CGMP violations include: - Failure to prepare and follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a), 111.210). - Failure to establish product specifications for identity, purity, strength, composition, and contamination limits of finished batches (21 CFR 111.70(e)). - Failure to maintain written records for production and process control systems, including procedures for receiving and rejecting components, packaging, and labels, and documentation of raw material examination (21 CFR 111.180(b)(1), 111.180(b)(3)). - Failure to maintain written records for equipment, specifically calibration procedures and records, and maintenance, cleaning, and sanitizing procedures (21 CFR 111.35(b)(1)(i), 111.35(b)(3), 111.35(b)(1)(iii)). - Failure to maintain written records for