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

During an inspection conducted from May 23 to June 2, 2023, at BayCare Integrated Service Center, LLC / dba BayCare Central Pharmacy, an outsourcing (503B) facility located in Temple Terrace, FL, the FDA observed a violation related to drug product labeling.

The sole observation, Observation 1, states that the labels of the firm's outsourcing facility drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, two types of information were missing:

a) **Dosage form:** This information was absent from labels for products such as Norepinephrine bitartrate 16 mg/250 mL, Oxytocin 30 units in 500 mL NaCl 0.9%, Ephedrine sulfate 25 mg/5 mL, Neostigmine methylsulfate 4 mg/4 mL, Succinylcholine chloride 100 mg/ 5 mL, and Iohexol 2.4 g Iodine/8 mL.

b) **A list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient, as required under section 503B(a)(10)(A)(iii)(X):** An example cited for this deficiency was Norepinephrine bitartrate 16 mg/2