483
FairyGene IncFDA 483 - FairyGene Inc - January 15, 2026
Record Details
FairyGene, Inc. in Bristol, PA, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in production and process controls, equipment cleaning, stability testing, facility design, and quality control unit procedures. These issues indicate a lack of adequate controls to ensure the quality and purity of their OTC drug products.
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ID · fed8f78c-8644-4226-9b2a-b37cb70b822e