FDA 483 - Degasa S.A. De C.V. - May 27, 2022

An FDA inspection of Degasa S.A. De C.V. in Jiutepec, Mexico, from May 23-27, 2022, revealed numerous deficiencies in their drug manufacturing operations. The firm was cited for issues including inadequate raw material sampling, incomplete laboratory records, lack of data integrity controls, and an insufficient stability program. Additionally, observations noted problems with facility construction, equipment design, contamination prevention, and an inadequate number of qualified personnel.