FDA 483 - Reliant Compounded Solutions Monroe, LLC - March 03, 2017

An FDA inspection conducted at Compounded Solutions in Pharmacy, LLC, located in Monroe, CT, from February 22 to March 3, 2017, identified multiple deficiencies related to drug manufacturing practices. The inspection report, issued on March 3, 2017, detailed five significant observations indicating potential non-compliance with current Good Manufacturing Practices (GMP).

Key issues included inadequate personnel gowning, where a pharmacist's non-sterile attire compromised a critical sterile production environment. The facility's environmental monitoring program was found to be deficient, lacking daily monitoring of classified sterile spaces and personnel, and failing to continuously monitor pressure differentials in aseptic processing areas. Structural deficiencies in aseptic areas were noted, specifically unsealed ceiling tiles and chipped caulking, which are not easily cleanable and pose contamination risks. Furthermore, equipment cleaning procedures were insufficient, with a non-disposable spatula inadequately sanitized between uses for different drug preparations. Finally, the facility lacked proper segregation for sterile and non-sterile drug production, with different products being compounded simultaneously on the same general lab bench without appropriate containment.

These observations highlight the need for Compounded Solutions in Pharmacy, LLC to implement comprehensive corrective actions to ensure the safety, quality, and purity of their drug products and to align their operations with regulatory requirements.