FDA 483 - BayCare Integrated Service Center LLC - June 02, 2023

During an inspection conducted from May 23 to June 2, 2023, the FDA identified deficiencies at BayCare Integrated Service Center, LLC, operating as BayCare Central Pharmacy, an outsourcing facility in Temple Terrace, FL. The primary observation cited a failure to comply with drug product labeling requirements under Section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act. Specifically, the inspection revealed that labels on various drug products, such as Norepinephrine bitartrate and Oxytocin, lacked essential information. This included the dosage form of the drug and a comprehensive list of all active and inactive ingredients, identified by their established names and specified quantities or proportions. These omissions are critical for ensuring proper drug identification and safe use, and are statutory requirements for 503B outsourcing facilities. The FDA 483 form documents these findings as inspectional observations, which require the firm to address the identified issues. BayCare Central Pharmacy is expected to implement corrective actions to ensure its drug product labels fully adhere to federal regulations, thereby mitigating potential risks associated with mislabeled medications and maintaining public health standards. The firm has the opportunity to respond to these observations.