FDA 483 - Auro PR Inc - May 31, 2023

Auro PR Inc, a drug product manufacturer in Caguas, PR, received a Form 483 with two observations following an FDA inspection from May 23-31, 2023. The inspection revealed significant deficiencies in the firm's stability program, including improper storage of stability samples and a lack of assurance that drug products are tested in their marketed container-closure systems. Additionally, the firm failed to ensure appropriate laboratory testing for objectionable microorganisms, evidenced by ineffective corrective actions and a lack of scientific rationale for changes in microbial monitoring procedures.