Zydus Lifesciences’ Gujarat Plant Receives Warning Letter
The pharma major, Zydus Lifesciences Ltd on 16 September announced that the US Food and Drug Administration (USFDA) has issued a warning letter for its...
Tag : warning letter
Aurobindo Pharma Shares Drop 6% after Eugia unit-III receives USFDA warning letter
Shares of Aurobindo Pharma Ltd. dropped 6% after touching a day’s high of Rs 1,527 on 16th August, following the company’s disclosure that its Eugia...
USFDA pulls back warning letter issued to Divis Lab
US health regulator has closed out the warning letter, which was issued to a unit of Divis Laboratories in Visakhapatnam, following evaluation of corrective actions...
Lupin receives warning letter for its Goa & Indore sites from USFDA
Lupin’s formulation manufacturing facilities at Goa and Indore (Pithampur Unit II), has received warning letter from USFDA. Earlier, Lupin received 3 Form 483 observations in Goa on...
Hetero Labs gets USFDA’s warning letter for norm violations
A warning letter has been issued by the US health regulator to Hetero Labs for significant violations of good manufacturing norms at its facility in...
USFDA has issued warning letter to Vista Pharma for Nalgonda unit
The US health regulator USFDA has issued a warning letter to the Hyderabad based Vista Pharmaceuticals over a significant violations of good manufacturing norms at...
USFDA has issued warning letter to Mylan for Nashik facility
A warning letter has been issued by the US health regulator to Mylan for violations of good manufacturing norms, including data integrity lapses and failure...
USFDA has issued warning letter to Unimark Remedies
The US Food and Drug Administration (USFDA) has warned Unimark Remedies on violation of good manufacturing practices at its two plants in Gujarat. It added...
Sri Krishna Pharma has been warned by USFDA, citing drug-data manipulation
The US Food and Drug Administration (FDA) has warned Sri Krishna Pharmaceuticals that supplies paracetamol and other drugs to more than 60 countries. The company...
USFDA has issued a warning letter to Mylan for lapses at 3 units
A warning letter has been issued by the US Food & Drug Administration (USFDA) to Mylan Laboratories for the violation of current good manufacturing practice...