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US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant - Vimarsana News

US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant

The regulator noted that visual inspectors manipulated particle and other defect counts on records to keep the finished product batches within rejection limits

FDA Roundup: December 1, 2023 - Vimarsana News

FDA Roundup: December 1, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Source: fda.gov
Cipla faces downgrade after USFDA warning letter - Vimarsana News

Cipla faces downgrade after USFDA warning letter

B&K Securities airs concerns considering Cipla’s significant exposure to the US market, constituting 28% of consolidated sales

Cipla share price rises more than 3%: overhang of USFDA warning letter for its Pithampur facility still remains. - Vimarsana News

Cipla share price rises more than 3%: overhang of USFDA warning letter for its Pithampur facility still remains.

Stock Market Today - Cipla's Pithampur manufacturing facility receives warning letter. The facility remains important as exports of respiratory products such as Albuterol generics to the US are made form this facility.

Law firm who won millions in kratom cases raises doubts about fed bill - Vimarsana News

Law firm who won millions in kratom cases raises doubts about fed bill

The Federal Kratom Consumer Protection Act (KCPA) was introduced in October, amid a fairly steady pace of enforcement actions against kratom products that the Food and Drug Administration considers to be “adulterated” or unlawful.