What happened
FDA states that its March 17–19, 2026, inspection of PReye’s drug manufacturing facility found significant finished-pharmaceutical CGMP violations. The firm manually filled multiple drug products from bulk liquid using a small flow hood on an office desk. FDA observed that the hood was neither certified nor qualified and was located in unclassified office space without HEPA filtration. FDA stated that these conditions lacked appropriate facilities, equipment, and process controls to protect products from microbiological contamination. FDA also found no quality unit function or written procedures defining its responsibilities. Basic procedures were absent, including complaint review, supplier qualification, release testing, change management, cleaning, disinfection, and deviation handling. FDA further reported missing batch numbers for sterile ophthalmic products manufactured since 2024, impairing traceability. The firm committed to cease U.S. manufacturing and distribution of PReye Vitamin SEE; it later voluntarily recalled the product because sterility testing had not been performed.
Why it matters
From a GMP perspective, FDA’s observations indicate that sterile drug handling occurred without the environmental and equipment controls described in the letter as necessary to prevent contamination risks. The absence of release-testing procedures, lack of sterility testing, inadequate cleaning and disinfection controls, and missing batch identifiers may limit assurance of product quality and traceability. The missing quality unit and deviation, supplier, complaint, and change-management procedures may also hinder consistent oversight and correction of manufacturing problems.
Key topics: Manual filling in an unqualified flow hood within unclassified office space, Absence of a quality unit and fundamental quality procedures, Missing batch traceability and lack of sterility testing