FDA WARNING_LETTER - Apollo Care LLC - March 13, 2018

This FDA Warning Letter, dated March 20, 2019 (Case# 574756), was issued to Apollo Care, LLC, an outsourcing facility registered under section 503B of the FDCA. The letter follows an inspection from February 12, 2018, to March 13, 2018, which identified serious deficiencies in sterile drug production and failure to meet 503B conditions. Apollo Care voluntarily recalled four lots of Vancomycin HCl IV injectable product in February and March 2018 due to stability concerns.

Violations include: - **Failure to meet 503B conditions:** Product labels lacked dosage form, compounding date, and storage/handling instructions. The facility failed to submit initial and complete semi-annual drug product reports. This renders their products ineligible for exemptions from drug approval, adequate directions for use, and Drug Supply Chain Security Act requirements. - **Adulterated drug products (501(a)(2)(A) FDCA):** Sterile products were prepared under insanitary conditions. Issues included continued aseptic production despite HEPA filter leaks, dirt/debris on ISO 5 LAF hoods, cracked/chipped laminate work surfaces in ISO 5 hoods, inadequate smoke studies, and aseptic operators lacking successful media fills under challenging conditions. - **Adulterated drug products (501(a)(2)(B)