FDA WARNING_LETTER - Betone S.A. de C.V. - November 10, 2023

The FDA inspected Betone S.A. de C.V. in Zapopan, Mexico, from November 6-10, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's December 1, 2023, response to the Form FDA 483 was deemed inadequate. Key violations include: 1) Failure to perform adequate laboratory testing for identity and strength of active ingredients (e.g., (b)(4) in (b)(4) wipes) prior to release (21 CFR 211.165(a)). 2) Failure to formulate drug products to contain at least 100% of the labeled active ingredient, resulting in subpotent (b)(4) wipe products (21 CFR 211.101(a)). 3) Failure to test incoming components for identity, purity, strength, and quality. 4) Failure to validate supplier Certificates of Analysis for components (21 CFR 211.84(d)(1) and 211.84(d)(2)), including inadequate testing of high-risk components like glycerin for DEG/EG. 5) Failure to support drug product expiration dates with appropriate, ongoing stability testing (21 CFR 211.137(a)). Additionally, the "DODY’S Antiseptic Hand Sanitizer Wipes" label had conflicting uses (rub vs. wash) under Section 505G of the FD&C Act. The firm's quality systems are inadequate, and FDA recommends engaging a qualified CGMP consultant for a comprehensive six-system audit. Betone S.A. de C.V. was placed on Import Alert 66-40. Failure to correct violations promptly may lead to continued refusal of admission for products, and FDA may withhold approval of new drug applications. A written response detailing corrective actions and recurrence prevention is required within 15 working days.