Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and
Panacea Biotec, Baddi facility was inspected by USFDA in Oct 2023- investigators Sandra A Boyd
Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies
Baxter initiated recall of one lot of Doxil (doxorubicin hydrochloride liposome injection) in U.S due
Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H
In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI
Velsipity (etrasimod) is an oral, once-daily, 2mg dose medication for adults with moderately to severely
In a company announcement, Biocon informed that it has received a CR (Complete response) letter
In an Interview to CNBCTV18 during visit to India, USFDA Commissioner touched on different topics
The Section 5200.14 of the Manual of Policies and Procedures (MAPP), Filing Review of Abbreviated
