FDA WARNING_LETTER - HealthTech International Inc. - November 16, 2018

On June 20, 2019, the FDA issued a Warning Letter to HealthTech International, Inc. following an inspection from November 14-16, 2018. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act, rendering their dietary supplement products adulterated under 21 U.S.C. § 342(g)(1) due to non-compliance with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111).

Key violations include: - Failure to establish and verify specifications for components and finished dietary supplements (21 CFR 111.70, 111.73, 111.75). The company lacked documentation for identity testing of dietary ingredients and confirmation of other components. - Inadequate Master Manufacturing Records (MMRs) and Batch Production Records (BPRs), lacking essential information like identity and weight of dietary ingredients, theoretical yield, and label descriptions. - Deficiencies in equipment calibration (21 CFR 111.25(a)) and maintenance, cleaning, and sanitizing procedures (21 CFR 111.25(c)), with no documented written procedures or records.

The FDA reviewed the company's November 27, 2018 response but found it inadequate due to a lack of supporting documentation for proposed corrective actions, such