Gelesis, Inc. – FDA 483, Jan 25, 2023

Gelesis, Inc. in Boston, MA, was inspected from January 19-25, 2023, revealing deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, with numerous CAPAs not meeting target completion dates or lacking effectiveness checks. Additionally, the inspection found that requirements for suppliers and contractors were not adequately established, as evidenced by missing re-qualification documentation for a Class A supplier.