PQ Pharmacy, LLC
FDA issued a warning letter to PQ Pharmacy, LLC (Brooksville, FL), a 503B outsourcing facility, following a March–April 2025 inspection that found serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility produced adulterated drug products due to insanitary conditions and CGMP violations, including poor aseptic practices, inadequate smoke studies, and failure to investigate batch discrepancies. Drug products — including semaglutide vials and ophthalmic solutions — were found to be unapproved new drugs and misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (3)
You do not have any FDA-approved applications on file for drug products that you compound.
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
Some of your facility's drug products, such as Prednisolone/Moxifloxacin HCl/Bromfenac PF Sterile Ophthalmic Solution and Prednisolone/Moxifloxacin HCl PF Sterile Ophthalmic Solution, did not include the established name of the drug.
Required actions (3)
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.
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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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