Betone S.A. de C.V. Warning Letter Details

Summary

Betone S.A. de C.V., a Mexican drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for over-the-counter wipe drug products during an FDA inspection in November 2023. The company failed to conduct adequate laboratory testing for identity and strength of active ingredients prior to releasing batches for distribution, in violation of 21 CFR 211.165(a). Although the firm claimed to have implemented a corrective procedure in their December response, the FDA found this response inadequate because it did not address products that had already been released without proper testing. Without comprehensive strength and identity testing before release, the company could not provide scientific evidence that its drug products met required specifications.