FDA's current 503B registry, Form FDA 483, and warning letter were verified. Warning-letter closeout status and state-board actions were not established.
U.S. Food and Drug Administration · 2025-05-15
Form FDA 483
FDA issued inspectional observations after a May 12-15, 2025 inspection of the Cary outsourcing facility.
Located in the heart of Raleigh's Research Triangle, Apothecary Pharma is dedicated to addressing national medication shortages with precision and care. Our microbiologists and staff are leaders in the pharmaceutical compounding industry, specializing in producing high-quality sterile and non-sterile medications that meet the rigorous standards set by the FDA and adhere to cGMP guidelines.
This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance.
Some of your facility’s drug products, such as Tirzepatide Injection 10 mg/mL and Semaglutide Injection 2.5 mg/mL, did not include the following information on the label: a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.
GLP Clinic Scout does not issue a blanket legitimacy verdict. This research record preserves 7 dated first-party or regulator citation(s), 2 regulatory/action record(s), and 5 explicitly unresolved field(s). Review the cited evidence and current license status before making a decision.
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