Apothecary Pharma, LLC
FDA issued a warning letter to Apothecary Pharma, LLC (Cary, NC), a 503B outsourcing facility, following a May 2025 inspection that revealed serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility compounded GLP-1 products including Tirzepatide Injection 10 mg/mL and Semaglutide Injection 2.5 mg/mL with inadequate labeling, deficient adverse event reporting procedures, and multiple insanitary aseptic processing practices that rendered drug products adulterated and misbranded. Because the 503B conditions were not met, the compounded drugs are also unapproved new drugs subject to FDA approval requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (5)
Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).
You do not have any FDA-approved applications on file for drug products that you compound.
some of your facility's drug products did not include the following information on the container: information to facilitate adverse event reporting and directions for use, including, as appropriate, dosage and administration.
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.
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.
Required actions (4)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
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