FDA 483 - Vital Rx, Inc. dba Atlantic Pharmacy and Compounding - August 10, 2017

An FDA Form 483 was issued to Vital Rx, Inc. dba Atlantic Pharmacy and Compounding following an inspection conducted from June 26 to July 20, 2017. The inspection identified significant deficiencies in the company's manufacturing practices for both sterile and non-sterile drug products.

Key violations centered on patient safety and quality control. For sterile drug preparations, especially intrathecal drugs, the company failed to perform essential endotoxin and sterility testing, raising concerns about product safety when using non-sterile starting materials. Furthermore, sterile processing environments and procedures were severely compromised, including the use of vials without assured sterility, inadequate integrity testing of sterilization units, poorly maintained cleanroom hoods with unsuitable filters and visible contamination, and the absence of a sporicidal cleaning agent.

The firm also demonstrated a lack of fundamental quality assurance, with media fill studies that did not adequately simulate aseptic operations and lacked critical data such as incubation conditions and negative controls. Comprehensive environmental monitoring for microorganisms in sterile production areas was entirely absent, including air, surface, and personnel testing.

For non-sterile drug production, particularly involving hazardous and potent compounds, the inspection observed inadequate cleaning protocols for work surfaces and reusable equipment, creating a high risk of cross-contamination. The cleaning methods employed were not validated to ensure effective removal and neutralization of drug residues.

These observations highlight a systemic failure to adhere to appropriate manufacturing controls, necessitating a comprehensive corrective action plan from Vital Rx, Inc. to ensure product quality and patient safety.