Drugs@FDA application timeline
1 dated FDA-coded AP submissions from 2023-12-05 through 2023-12-05, connected to 0 source-defined action assignments and 0 official document links.
Reviewed identity mapping
Exact application-number connection
2026-04-01 · Class II · Ongoing
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
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
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 →2026-05-13 · Class II · Ongoing
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 →Newest first
2023-12-05 · status AP
No source action-type assignment was retained for this submission.
No eligible official document row was listed for this submission in the retained archive.
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.