FDA 483 - Colonia Care Pharmacy - July 26, 2021

An FDA inspection of Colonia Care Pharmacy, a compounding pharmacy, was conducted from June 9 to July 26, 2021, resulting in the issuance of an FDA Form 483. The inspection revealed critical observations concerning facility cleanliness and manufacturing practices. Key issues included significant non-microbial contamination in the production areas, specifically within the ISO 5 Laminar Flow hood and an adjacent unclassified compounding room. Observed contaminants ranged from unknown residues and discoloration to dust/filth on HVAC vents, equipment, and surfaces, along with rust on storage shelving.

Furthermore, the pharmacy demonstrated inadequate and infrequent use of sporicidal agents in its ISO 5 aseptic processing area. Cleaning logs lacked scientific rationale for sporicidal frequency, critical surfaces were not consistently cleaned, and compounding occurred even when cleaning records indicated otherwise. Lastly, the facility produced highly potent drugs such as betalactams and opioids without appropriate containment, segregation, or effective cleaning protocols to prevent cross-contamination. Cleaning activities following compounding operations were also not documented. These observations necessitate immediate and comprehensive corrective actions to ensure compliance with the Federal Food, Drug, and Cosmetic Act and to safeguard product quality and patient safety.