IntegraDose Compounding Services LLC – FDA Warning Letter, Sep 19, 2018

This FDA Warning Letter, dated May 6, 2020 (Case #: 592187), was issued to IntegraDose Compounding Services, LLC following an inspection from September 10-19, 2018. The facility, registered as an outsourcing facility under section 503B of the FDCA, was found to have produced drug products that failed to meet 503B conditions and exhibited serious deficiencies in sterile drug production, posing patient risks.

Key violations include: - **Failure to meet 503B conditions**: Drug product labels lacked active/inactive ingredient lists with quantities, and adverse event reporting procedures were inadequate (e.g., no definition of serious adverse event, no reporting timelines). This renders their products ineligible for 503B exemptions from drug approval, adequate directions for use, and DSCSA requirements. - **Adulterated Drug Products (Section 501(a)(2)(A) & (B) FDCA)**: - **Insanitary Conditions**: Technician leaning into ISO-5 hood, inadequate media fills (not under challenging conditions), and insufficient dynamic smoke studies, indicating potential contamination risk. - **CGMP Violations**: Failure to thoroughly investigate unexplained discrepancies/failures (21 CFR 211.192) and failure to establish/follow procedures to prevent microbiological contamination, including validation of aseptic/sterilization processes