FDA 483 - Keystone Pharmacy - November 03, 2017

This FDA Form 483 documents observations from an inspection of Keystone Pharmacy, a producer of non-sterile drugs, located at 4021 Cascade Rd SE Ste 50, Grand Rapids, MI 49546-3720. The inspection was conducted from October 17, 2017, to November 3, 2017, and the report was issued to David J. Miller, Pharmacist-In-Charge/Co-owner.

The primary observation noted was the production of highly potent drugs without adequate segregation and cleaning of utensils to prevent cross-contamination. Specifically: A. There were no defined or labeled areas for storing "clean" and "unclean" drug production equipment/utensils, including small plastic containers reused for repackaging bulk chemical materials. Equipment like capsule filling trays, molds, spatulas, mortars, pestles, and spinners were stored on portable carts or in a 3-compartment sink in the cleaning area without status identification. B. Small, reusable plastic containers used for repackaging bulk chemical materials, including hormonal creams/ointments and excipients, were not dedicated, and there was no method to track or identify their previous contents after cleaning. An example cited was the use of such a container for testosterone in a prescription, with no way to determine its prior use.