FDA 483 - CD Pharmacy, LLC dba Red Rock Pharmacy - July 31, 2026

During an inspection from July 21 to July 31, 2026, the FDA identified several significant safety and quality control concerns at CD Pharmacy, LLC (dba Red Rock Pharmacy) in Springville, Utah. The facility, which produces both sterile and nonsterile medications, was found to be operating under conditions that could lead to product contamination. Key violations included the release of injectable drugs with questionable purity. In one instance, a batch was redistributed after a glass particle was suspected, yet the pharmacy failed to investigate the source of the particle or provide data to support the drug"s extended shelf life. The pharmacy also failed to properly validate its sterilization processes. Specifically, test runs used to verify staff performance utilized an incorrect growth medium intended for food testing rather than pharmaceutical standards. Additionally, airflow studies meant to prove the cleanliness of the workspace did not reflect the crowded, high-activity conditions of actual production. Inspectors observed numerous poor hygiene practices, such as technicians touching sterile bottle stoppers with their hands, blocking clean air filters with equipment, and leaving sterile tools exposed to unprotected air for long periods. Furthermore, the pharmacy used uncalibrated equipment for critical safety tests and demonstrated inadequate cleaning procedures when handling hazardous drugs, posing a risk of cross-contamination. These observations were issued under the Federal Food, Drug, and Cosmetic Act. While this report does not represent a final legal determination, Red Rock Pharmacy is expected to respond to the FDA with a corrective action plan to address these deficiencies.