PQ Pharmacy, LLC
Outcome
FDA issued a warning letter on October 10, 2025, citing PQ Pharmacy's Brooksville, Florida 503B outsourcing facility for producing sterile drug products under insanitary conditions — including an operator resting arms on the aseptic work surface during filling — causing the compounded products to be adulterated and not eligible for FDCA exemptions from approval requirements.
Details
PQ Pharmacy, LLC — 503B Aseptic Technique Violations / FDA Warning Letter (2025)
Outcome: FDA issued a warning letter on October 10, 2025, after a March 25–April 4, 2025 inspection of PQ Pharmacy's Brooksville, Florida 503B outsourcing facility found sterile drug products produced under insanitary conditions — including an operator resting arms on the hood work surface during aseptic filling — rendering all drug products adulterated and ineligible for FDCA exemptions that apply to qualified outsourcing facilities.
PQ Pharmacy, LLC operates a 503B outsourcing facility at 15215 Technology Drive, Brooksville, Florida. The facility registered with FDA as a 503B outsourcing facility on October 29, 2020, most recently renewed November 26, 2024. As a 503B facility, PQ Pharmacy is subject to current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210 and 211, and must produce sterile drug products under conditions that ensure sterility assurance for patient safety.
FDA investigators conducted a comprehensive inspection from March 25 to April 4, 2025. The inspection documented that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health — meeting the FDCA's adulteration standard under section 501(a)(2)(A). Specific violations included an operator directly resting their arms on the work surface of the laminar airflow hood during aseptic drug product filling operations, a fundamental breach of aseptic technique that compromises the sterile barrier.
Because the drug products were produced under conditions that did not meet all requirements of FDCA section 503B, they failed to qualify for the statutory exemptions from FDA drug approval requirements under section 505 and from the requirement that drug labeling bear adequate directions for use. This means the products were legally distributed as unapproved new drugs in addition to being adulterated. The warning letter required a written corrective action response within 15 working days.
Primary Source: PQ Pharmacy, LLC - 715795 - 10/10/2025 | FDA
How Crucible Prevents This
Aseptic technique violations — including resting arms on the hood work surface during sterile drug product filling — are training and culture failures, not documentation failures. However, Crucible's session-gate enforces a documented pre-production checklist including gowning procedure confirmation and aseptic technique refresher attestation before each production run. A facility where operators contact sterile work surfaces during production is a facility where no verified pre-production protocol confirmation is happening. The 503B registration status (since 2020) means the facility had five years of CGMP obligations before these basic violations were found on inspection.
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