FDA 483 - SriSai Biopharmaceutical Solutions LLC - February 23, 2023

This FDA Form 483 report details observations made at SriSai Biopharmaceutical Solutions LLC in Frederick, MD, a drug distributor/warehouse. The inspection revealed significant deficiencies in component control, drug product storage conditions, supplier qualification, and equipment calibration. These issues indicate a lack of robust quality systems necessary to ensure the identity, strength, quality, and purity of drug products.