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Warning letter woes: Dr Reddy’s expects FDA inspection of AP plant by year-end expresspharma
August 02, 2019
US FDA had issued warning letter in November 2015 relating to Current Good Manufacturing Practice deviations at Dr Reddy’s API manufacturing facilities at Srikakulam.
Indoco’s Goa Plant I receives Warning Letter from US FDA expresspharma
July 17, 2019
Indoco Remedies has received a Warning Letter from The United States Food and Drug Administration for its Oral dosages Plant, situated at L -14, Verna Industrial Road, Goa, after an inspection which was carried out in January 2019.
Strides Pharma Puducherry unit receives warning letter from US FDA expresspharma
July 04, 2019
The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator
FDA Takes Action Against Marketer of Unapproved Products Claiming to Treat Addiction, Chronic Pain and Other Serious Conditions drugs
March 20, 2019
he U.S. Food and Drug Administration today posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with
Teva plant tagged with warning letter for issues making schizophrenia drug fiercepharma
March 08, 2019
For years now, Teva has had difficulty with the laser drilling of a schizophrenia drug so that patients get the right dose. The FDA, having finally tired of the company being unable to resolve the issues, has now slapped the plant in Florida with a warnin
Dr. Reddy’s oncology drug plant escapes cloud of FDA warning letter fiercepharma
February 24, 2019
Just days after bad news about manufacturing wreaked havoc with Dr. Reddy’s shares, the drugmaker was able to report something positive.
FDA finds more issues at Lupin plant it spanked in warning letter fiercepharma
January 30, 2019
The FDA in 2017 ripped Indian drugmaker Lupin in a warning letter for not learning from past mistakes. In a new visit to one of the two plants cited in that letter, the FDA has again found issues.
Mylan West Virginia plant tagged with warning letter by FDA fiercepharma
November 21, 2018
The other shoe has finally dropped on Mylan’s troubled manufacturing plant in West Virginia. The drugmaker acknowledged Tuesday that the FDA this month issued a warning letter for the problems at the massive site.
Apotex plant in India hit with third warning letter in 4 years fiercepharma
August 17, 2018
When the FDA issued warning letters in 2014 and 2015 to the Apotex Research Private plant, it was in part because of testing methods that left doubt about the quality of products coming out of the manufacturing facility in Bangalore, India. Fast-forward t
US FDA issues warning letter to Hyderabad-based Vista Pharma financialexpress
July 14, 2017
The warning letter summarises significant violations of CGMP regulations