Windlas issued a warning letter by the US FDA after the regulator finds the manufacturer’s response inadequate to justify wrongdoings at its India facility.
A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.
Xinxiang Tuoxin Biochemical has received a US FDA warning letter after manufacturing equipment at two API facilities were found to be in a state of disrepair.
As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.
Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.
Hospira has received a US FDA Warning Letter at an Australian injectables facility months after workers asked the firm not turn the site into “the new Rocky Mount.”
GlaxoSmithKline has issued a recall of its antidepressant drug Paxil after receiving a US FDA Warning Letter for failing to fully investigate contamination issues at an Irish API plant.
A Hospira plant in India that was issued with a US FDA warning letter last summer has been criticised by the agency again following an inspection last month.
Germany-based CMO CPM Contract Pharma was hit with the first US FDA warning letter for failing to self-identify its manufacturing facility and pay the facility fee required by the Generic Drug User Fee Amendments of 2012.
The US FDA has sent Wockhardt a warning letter for its manufacturing plant in Waluj, India just days after UK authorities issued the site with a certificate of non-compliance.
Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new bar" in enforcement activity from...
Fercy Personal Care Products received an FDA warning letter after quality staff handed inspectors just two pages from a notebook as ingredient records.
Israeli drugmaker Teva Pharmaceutical Industries has received a US FDA warning letter criticising laboratory operations at its manufacturing facility in Jerusalem.
Irish CRO Icon has received a US Food and Drug Administration (FDA) warning letter relating to two studies of an antibiotic it conducted between 2004 and 2006.
News of Bayer’s selection of ex-Thermo Fisher Scientific boss Marijn Dekkers as its CEO was somewhat overshadowed by a new FDA warning letter about quality testing at its manufacturing facility in Bergkamen, Germany.
Food and Drug Administration (FDA) staffing and timetabling
problems have delayed the re-inspection of Wyeth's Puerto Rico
site, the company said this week.
Patheon has resumed normal production of Omnicef antibiotic powder
after it voluntarily suspended production in September at it
facility in Carolina, Puerto Rico, due to a US Food and Drug
Administration (FDA) manufacturing warning.
