USFDA inspects JB Pharma’s manufacturing facility at Panoli, Gujarat
The facility received no observations and no Form 483 was issued
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Form 483
US FDA issues Form-483 with eight observations to Lupin’s drug, API production facilities in…
The US Food and Drug Administration (FDA) had inspected the Mandideep Unit-1 facility in Madhya Pradesh from 14th November, 2022,…
US FDA asks Panacea Biotec to take corrective measures at Himachal unit
The US Food and Drug Administration (FDA) had inspected the Baddi unit of its subsidiary, Panacea Biotec Pharma from 30th May to…
Aurobindo Pharma subsidiary’s plant gets one observation from US FDA
The plant is owned by Aurolife Pharma, a wholly-owned step down subsidiary of the company
US FDA issues Form 483 to Cipla’s facility in MP
The FDA has censured the drug maker due to unclean equipment and lack of data
Aurobindo Pharma’s Andhra unit gets three US FDA observations
The company will respond to the FDA within the stipulated timeline and work closely with the regulator to address the observations…
Sun Pharma gets Form 483 from US FDA for regulatory violations at Halol plant
The US Food and Drug Administration (FDA) conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from…
US FDA issues Form 483 to Lupin’s Goa plant
The company has received seven observations from the US health regulator
Alkem’s St Louis facility gets two observations from US FDA
The US FDA had conducted an inspection of the company’s manufacturing facility from 14-18, June 2021
US FDA makes five observations after Alembic Pharma facility inspection
Alembic Pharma informed that “none of the observations are related to data integrity and are procedural in nature”