FDA 483 - ProCaire, LLC - May 17, 2019

ProCaire, LLC, a medical gas manufacturer in Plainville, MA, was cited for significant deficiencies during an FDA inspection. Observations included inadequate contamination controls for oxygen filling equipment, severe data integrity issues with electronic batch records, and a lack of proper calibration for critical equipment. The firm also failed to maintain defined storage areas, establish written QC procedures, and include complete labeling information in batch records, indicating a broad breakdown in quality control and manufacturing practices.