2026-07-08 · Class II · Ongoing
D-0723-2026 · Lupin Pharmaceuticals Inc.
Glucagon · CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Open attributed report →FDA enforcement report year
9 dated reports mapped only through exact reviewed application-number annotations.
2026-07-08 · Class II · Ongoing
Glucagon · CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Open attributed report →2026-05-27 · Class II · Ongoing
Liraglutide · Presence of particulate matter: a white thread-like structure in the cartridge
Open attributed report →2026-05-13 · Class II · Ongoing
Octreotide · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Open attributed report →2026-04-15 · Class II · Ongoing
Lanreotide · Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Open attributed report →2026-04-15 · Class II · Ongoing
Lanreotide · Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Open attributed report →2026-04-01 · Class II · Ongoing
Octreotide · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Open attributed report →2026-04-01 · Class II · Ongoing
Octreotide · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Open attributed report →2026-04-01 · Class II · Ongoing
Octreotide · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Open attributed report →2026-01-21 · Class II · Ongoing
Lanreotide · Presence of Particulate Matter.
Open attributed report →