US FDA issues warning to Mylan for Telangana plant
It has also recommended the company to engage a cGMP Consultant
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Browsing Tag
Form 483
Alembic Pharma receives four observations from USFDA for Panelav facility
"The US Food and Drug Administration (USFDA) had conducted an inspection at Alembic Pharmaceuticals general oral solid formulation…
Alkem Labs gets EIR from US FDA for Baddi facility
The Baddi facility was inspected by the US FDA from February 17 to 21, 2020
Alkem Laboratories said the US health regulator has…
Biocon gets three observations from US health regulator for Malaysia facility
The FDA has set a target action date for its insulin glargine application in June 2020
USFDA issues Form 483 with five observations to Biocon’s Bengaluru facility
Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in…
USFDA inspects Alembic Pharma’s facility in Karkhadi
The US health regulator issued a form 483 with two observations
Dr Kiran Mazumdar-Shaw honoured with Australia’s highest civilian honour
The award was given for her significant service to advancing Australia's bilateral relationship with India, particularly in…
US FDA issues three observations to Ipca Laboratories Silvassa unit
In regulatory filing to BSE, Ipca Laboratories said US FDA conducted inspection of its formulations manufacturing unit from from…
US FDA completes audit of Dr Reddy’s Louisiana-based facility
No Form 483 was issued at the end of the inspection, the company said in a regulatory filing, the company said
USFDA issues 12 observations for three Biocon units in Malaysia
The inspection across these three units concluded with 12 observations issued on the Form 483