FDA 483 - Abbott Laboratories Inc. - March 29, 2024

Abbott Laboratories Inc. in Casa Grande, AZ, received a Form 483 citing significant issues in infant formula manufacturing. The inspection revealed a lack of adequate process controls to prevent microbial contamination, particularly Cronobacter sakazakii, stemming from environmental monitoring failures, persistent water leaks, and poor transition zone hygiene. Additionally, the firm failed to maintain sanitary building conditions and lacked proper equipment monitoring to prevent metal contamination in finished products.