Colonia Care Pharmacy – FDA Warning Letter, Apr 15, 2016

On October 12, 2017, the FDA issued Warning Letter WL # 537790 to Colonia Care Pharmacy, following an inspection from March 3 to April 15, 2016. The inspection revealed serious deficiencies in the production of sterile drug products, rendering them adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Key violations included producing purportedly sterile drugs using stock solutions sterile-filtered into unclassified areas and then filled into finished vials without further sterilization. The aseptic processing area (ISO 5) was also located in an unclassified room, and the firm failed to demonstrate adequate protection of this ISO 5 area, posing a significant contamination risk.

Colonia Care Pharmacy voluntarily recalled all lots of compounded injectable drug products from sterile-filtered stock solutions and ceased their production on July 28, 2016. However, the FDA found the firm's corrective actions regarding insanitary conditions insufficient due to a lack of supporting documentation, specifically for "smoke testing under dynamic conditions." The FDA remains concerned about the current location of the ISO 5 aseptic processing area.

The FDA strongly recommends a comprehensive assessment of operations by a third-party consultant if the firm resumes production of sterile-filtered drug products. The firm must respond within fifteen working days with corrective steps and supporting documentation, and notify the FDA 15 days prior to resuming production of sterile