Magellan Rx Pharmacy, LLC – FDA Warning Letter, Dec 22, 2016

On September 11, 2017, the FDA issued Warning Letter WL # 536134 to Magellan Rx Pharmacy, LLC, following an inspection from December 6 to December 22, 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 include: 1. **Deficient Facility Design:** The ISO 7 cleanroom had a lower pressure differential than the adjacent unclassified anteroom, allowing lower quality air influx. Holes were observed in ceiling tiles, a sink was near the ISO 5 area, and dust-collecting ledges were present. 2. **Inadequate Cleaning and Disinfection Program:** Non-sterile wipes and disinfectant were used in aseptic processing areas. The ISO 5 work area was not disinfected before operations, and items were not disinfected when transferred between areas of differing air quality. Environmental samples showed microbial contamination (fungi, spore-forming bacteria) in the ISO 7 cleanroom. 3. **Poor Aseptic Practices:** Personnel donned sterile gloves in the unclassified anteroom, used non-sterile equipment in the ISO 5 work area, and wore uncovered jewelry in the ISO 7 cleanroom.

The FDA found the firm's January 13 and March 30,