MCACO, LTD
FDA issued a warning letter to MCACO, LTD (Grand Prairie, TX) following a November–December 2021 inspection that revealed serious Current Good Manufacturing Practice (CGMP) violations in the production of dietary supplements. Violations included failure to establish finished product and component specifications, failure to qualify suppliers via confirmed certificates of analysis, inadequate laboratory testing methodologies, incomplete master manufacturing records, and backdated batch production records. FDA warned that failure to adequately address these violations may result in legal action including seizure and injunction.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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