FDA 483 - Axium Healthcare Pharmacy dba Balanced Solutions Compounding - March 15, 2013

This FDA Form 483 documents observations made during an inspection of a drug manufacturing facility. The facility was cited for multiple deficiencies related to quality control, equipment maintenance, aseptic processing, environmental monitoring, sterilization validation, personnel hygiene, and product testing.

Specifically, drug products failing to meet quality standards were not rejected. Equipment and utensils were not adequately cleaned, maintained, or sanitized. Procedures to prevent microbiological contamination of sterile drug products were not established or followed, and the environmental monitoring system in aseptic processing areas was deficient. The sterilization process for injectable products had not been validated. Personnel clothing was deemed inappropriate for their duties. Each batch of sterile and pyrogen-free drug product was not laboratory tested for conformance. The facility lacked separate or defined areas to prevent contamination or mix-ups during the receipt, identification, storage, and withholding of components and containers. Finally, an adequate number of drug product batches were not tested, nor were records maintained, to determine appropriate expiration dates. These observations indicate significant issues with the facility's quality system and manufacturing controls, potentially impacting drug product safety, identity, strength, quality, and purity.