FDA 483 - OrBion Pharmaceuticals Private Limited - October 27, 2025

OrBion Pharmaceuticals Private Limited in Sriperumbudur, India, was cited for significant deficiencies in its quality control and laboratory practices. The inspection revealed a lack of established procedures to prevent objectionable microorganisms in non-sterile drug products, leading to fungal contamination and uninvestigated microbial growth. Additionally, laboratory records were incomplete, with uncounted microbial growth and the use of defective media compromising test integrity.