USFDA issues zero observations for Gland Pharma Visakhapatnam API facility Ruchika Sharma28 Jan 2023 1:00 PM ISTVisakhapatnam: Gland Pharma has recently announced that the company has received zero observations from the US Food and Drug Administration (USFDA)...
Zydus Lifesciences gets zero USFDA observations for Moraiya facility Ruchika Sharma28 Jan 2023 12:28 PM ISTAhmedabad: Zydus Lifesciences Limited has recently announced that the US Food and Drug Administration (USFDA) has concluded a Pre-Approval Inspection...
Torrent Pharma gets USFDA OAI status for Gujarat facility Ruchika Sharma24 Jan 2023 3:14 PM ISTAhmedabad: Torrent Pharma has announced that the Company has received a communication from the US Food and Drug Administration (USFDA)...
USFDA inspection: Indoco Remedies gets 9 observations for Goa facility Ruchika Sharma24 Jan 2023 2:30 PM ISTMumbai: Indoco Remedies has announced that the United States Food and Drug Administration (USFDA) has issued 9 observations after GMP...
Aurobindo Pharma arm gets 2 USFDA observations for Unit I, III in Telangana Ruchika Sharma19 Jan 2023 10:56 AM ISTHyderabad: Aurobindo Pharma has announced that the US Food and Drug Administration (USFDA) has issued Form 483 with 2 observations at the end of the...
USFDA issues 3 observations for Granules India Gagillapur facility Ruchika Sharma16 Jan 2023 2:30 PM ISTHyderabad: Granules India has recently announced that US Food and Drug Administration (USFDA) has concluded Pre-Approval Inspection (PAI) with three...
Lupin gets 2 USFDA observations for Somerset facility Ruchika Sharma16 Jan 2023 1:15 PM ISTMumbai: Lupin has announced that the company has received two observations from the US Food and Drug Administration (USFDA) at the closure of...
USFDA inspection: Piramal Pharma gets Form 483 with 6 observations for Lexington facility Ruchika Sharma12 Jan 2023 11:32 AM ISTThe observations were classified under VAI (Voluntary Action Indicated) and does not relate to data integrity.
Gland Pharma gets UFSDA EIR for Dundigal Facility Ruchika Sharma5 Jan 2023 2:30 PM ISTHyderabad: Gland Pharma has received the Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices...
USFDA inspection: Alembic Pharma gets Form 483 with 5 observations Ruchika Sharma19 Dec 2022 2:55 PM ISTVadodara: Drugmaker, Alembic Pharma, has recently announced that the company has received a Form 483 with 5 procedural observations from US Food...
USFDA issues warning letter to Sun Pharma Halol facility Ruchika Sharma17 Dec 2022 12:30 PM ISTThe Warning Letter issued by USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can...
Glenmark Pharma Goa facility gets USFDA warning letter Ruchika Sharma12 Dec 2022 11:33 AM ISTThe US health regulator also pointed out that the company failed to prepare batch production and control records with complete information relating to...
