FDA WARNING_LETTER - Custom Compounding Centers, LLC - December 13, 2012

On May 15, 2013, the FDA issued a Warning Letter to Custom Compounding Centers, LLC, following an inspection from November 14 to December 13, 2012. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and had serious deficiencies in sterile drug product manufacturing, potentially leading to contamination.

Key violations included: - **Unapproved New Drugs:** The firm manufactured and distributed unapproved new drugs, such as Methylprednisolone Acetate Sterile Injectable, without FDA-approved applications, violating FDCA sections 301(d) and 505(a). - **Misbranded Drugs:** Products were misbranded under FDCA section 502(f)(1) because they lacked adequate directions for use by laypersons, as they are intended for conditions not amenable to self-diagnosis. - **Adulterated Drugs (CGMP Violations):** Significant Current Good Manufacturing Practice (CGMP) violations caused drugs to be adulterated under FDCA section 501(a)(2)(B). These included: 1. Failure to establish adequate HEPA-filtered air supply under positive pressure in aseptic areas (21 CFR 211.42(c)(10)(iii)). 2. Failure to thoroughly investigate batch failures or components not meeting specifications (21 C.F.R. 21