2026-04-15 · Class II · Ongoing
D-0423-2026 · Cipla USA, Inc.
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 →Drugs@FDA application timeline
ANDA217193
1 dated FDA-coded AP submissions from 2024-05-21 through 2024-05-21, connected to 0 source-defined action assignments and 1 official document links.
1Dated AP submissions
0Action assignments
1Official documents
1Exact enforcement reports
1Reviewed profile mappings
Reviewed identity mapping
Connected peptide profiles
Exact application-number connection
FDA enforcement reports
Newest first
Submission and document chronology
2024-05-21 · status AP
Original submission 1
No source action-type assignment was retained for this submission.
1 official document
- Letter ↗2024-06-20 · FDA document 78843
Source archive dated 2026-08-24; observed 2026-08-24T21:23:49.000Z; reviewed 2026-08-24. Observation SHA-256: 6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b.