FDA 483 - Medlife Pharmacy and Compounding - April 18, 2018

During an FDA inspection conducted from April 9 to April 18, 2018, Medlife Pharmacy and Compounding, a producer of non-sterile drugs, received ten significant observations. The firm was cited for critical deficiencies related to its production and quality control systems, indicating potential non-compliance with current Good Manufacturing Practices (cGMP).

Key violations included the absence of a written stability testing program, leading to unsupported expiration dates for drug products. The facility demonstrated inadequate separation and control systems, risking cross-contamination between potent and non-potent compounds due to shared equipment in a single production hood. Additionally, the inspection revealed a lack of procedures to prevent microbiological contamination for drugs purported to be sterile, and a failure to perform essential microbial and potency testing on both components and finished products before release.

The firm also lacked proper record-keeping for equipment cleaning and maintenance. Furthermore, critical instruments, such as micro-analytical balances and thermometers, were either uncalibrated or had expired calibrations. Utensils and containers were inadequately cleaned, using only tap water, further compromising product quality and safety. Medlife Pharmacy is required to address these observations by implementing corrective actions to ensure compliance with regulatory standards.