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Drugmakers should review their inspection standard operating procedures for producing off-site records and allowing FDA investigators to take photos or conduct interviews of employees, following new agency guidance on the topics. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, becoming another Indian facility to get a warning letter for data integrity violations. Read More
The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
The FDA has warned an Oregon compounder for multiple GMP violations, including poor sterile drug manufacturing practices, using ingredients that aren’t FDA-approved and not receiving valid prescriptions for drugs it was producing. Read More
The FDA barred beleaguered drugmaker Ipca Laboratories from shipping drugs to the U.S because of good manufacturing practice violations — the 27th time the agency has cracked down on GMP violations at Indian drug facilities in the last two years. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility in a week to get a warning letter for data integrity violations. Read More
The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
Drugmakers should review their inspection standard operating procedures for producing off-site records and allowing FDA investigators to take photos or conduct interviews of employees, following new agency guidance on the topics. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More
Luitpold Pharmaceuticals was chided by the FDA for failing to properly investigate how severe roof leaks in 2013 and 2014 affected production. Read More
Contract OTC manufacturer Gopers Int. doesn’t have a quality control unit, keep batch records or properly train its employees, according to an FDA Form 483 that features a litany of quality violations. Read More