A resource-intensive investigation by FDA of Ameridose’s sterile manufacturing operations has found a markedly similar gap from acceptable practice to that agency investigators found at the New England Compounding Center (NECC) – the sister company to Ameridose responsible for the fungal meningitis outbreak.
A contingent of 17 experienced FDA investigators and microbiologists – including Center for Drug Evaluation and Research (CDER) compliance office sterility expert Richard Friedman – left Ameridose with a 15-item, 20-page 483 on November 9.
The findings of significant sterility control and testing deviations were strikingly similar to those found at NECC in an inspection that concluded two weeks earlier. [See IPQ’s Special Report, “The Current Crisis in Pharmacy Compounding and its Implications”].
FDA began the inspection of Ameridose in the wake of the meningitis outbreak caused by fungal contamination of products manufactured by NECC, which is owned and managed by the same family.
Like NECC, Ameridose is classified as a sterile compounding company. However, because its intent was to produce batch drugs for hospitals rather than filling patient-specific prescriptions, it was required to register as a manufacturer with FDA as well as with the Massachusetts Board.