FDA 483 - Apollo Care, LLC - March 27, 2025

Apollo Care, LLC, an outsourcing facility located in Columbia, MO, underwent an FDA inspection from March 10 to March 27, 2025. The inspection revealed significant compliance issues primarily related to quality control and sterile drug production processes.

Key violations included the absence of written responsibilities and procedures for the quality control unit, specifically regarding the removal of a handwashing sink from the ISO 8 Hallway/Anteroom without proper evaluation and approval. Additionally, the facility"s cleaning documentation was found deficient, lacking validation for electronic records as per Part 11 requirements.

Further observations highlighted inadequate procedures to prevent microbiological contamination in sterile drug products. Notably, non-sterile bulk drug solutions were exposed to cleaning agents during storage in the ISO 8 Anteroom, potentially compromising the quality and purity of the finished products. The facility also improperly classified and used its Hallway/Anteroom as both ISO 8 and ISO 7 areas without appropriate controls.

Moreover, Apollo Care failed to investigate microbiological contamination on operator gowning within critical ISO 5 areas, resulting in the distribution of compounded drug products with contamination levels exceeding acceptable limits. Specific examples included contamination incidents involving drugs like Fentanyl and Ketamine, where no documented investigations or risk assessments were conducted.

The FDA requires Apollo Care to address these violations by implementing corrective actions to ensure compliance with regulatory standards, particularly focusing on establishing robust quality control procedures and ensuring the integrity of sterile drug production processes.