Sun Pharma’s got clearance For Halol Facility From US Regulator
Sun Pharma received the EIR or Establishment Inspection Report from the US Food and Drug Administration (FDA) for its Halol facility in... Read More
DRL’s API plant in Medak and Biocon’s Malaysian Plant got USFDA 483 observations
Posted on19 Mar 2018
Tags483, 483 OBSERVATION, 483 observations, fda 483 observation, form 483 observation, usfda 483 form
Comments0
Dr Reddy’s Laboratories received the US Food and Drug Administration has issued a Form 483 with four observations after inspecting its active... Read More
Sri Krishna Pharma received USFDA warning for cGMP norm violations
The Hyderabad-based Sri Krishna Pharmaceuticals has been warned by US health regulator for violations of good manufacturing practices at its facility, including... Read More
USFDA issues warning letter to Lupin’s Goa Plant
The US Food and Drug Administration (USFDA) has issued Form 483 to Lupin’s Goa plant. The Goa plant supplies drugs (oral solids... Read More
Cipla gets 483 observation for Indore unit
Indian drug maker Cipla Ltd. has been served 483 observations by the US FDA for its Indore-based manufacturing unit as part of an... Read More
What is Form 483 in regulatory affairs?
Posted on27 Nov 2014
Comments0
Dr Reddy’s Laboratories has received inspectional observations from the US Food and Drug Administration (FDA) for one of its active pharmaceutical ingredients... Read More