FDA 483 - Cephas Life Sciences Private Limited - May 18, 2023

Cephas Life Sciences Private Limited, a chemical analytical laboratory in Taramani, Chennai, received a Form 483 with three observations. The inspection revealed deficiencies in laboratory controls, including scientifically unsound out-of-specification procedures and unsupported extraction methods. Additionally, the firm failed to justify deviations from written sampling plans and lacked a quality agreement for contract manufactured drug products.