Granules India’s Vizag facility completes US FDA inspection with zero 483 observations
This facility manufactures APIs and formulations of oncology and non-oncology products
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Browsing Tag
US FDA inspection
US FDA designates Cipla’s Goa plant as ‘Official Action Indicated’
The US FDA may continue to withhold product approvals from this facility till the outstanding observations are resolved
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 completes inspection at Stride Pharma’s Singapore facility
The inspection was completed successfully with Zero 483 observations
US FDA probe of Abbott facility finds quality control issues
The inspection from 31st January to 18th March showed that Abbott did not have a control system covering all stages of processing…
Aurobindo Pharma gets warning letter from US FDA for API facility
The action follows the recent inspection of the facility by the US Food and Drug Administration (FDA) in August 2021, the…
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
The conundrum of USFDA inspections
Alok Ghosh, Ex-President - Global Technical Services, Lupin, shares insights on the challenges that India Pharma Inc faces with US…
Strides completes US FDA inspection at its Alathur facility
The company announced a successful completion of inspection at the facility by US FDA with “Zero 483 observations”