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Two pharmaceutical giants — AstraZeneca and Eli Lilly — endured 483 knocks recently: AZ for releasing an out-of-spec bilayer tablet and Lilly for lapses in aseptic technique. Read More
The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have arrived with more questions of their own. Read More
Six manufacturers of numbing gels, creams and sprays marketed to relieve pain from cosmetic procedures have received FDA Warning Letters for concentrations of lidocaine in their products in excess of the allowance of 4 percent for OTC topical pain relief products. Read More
The recruitment and retention of Bioresearch Monitoring (BIMO) program investigators has been a thorn in the side of the FDA that’s negatively impacted trial inspections, a Government Accountability Office (GAO) audit has found. Read More
Sterile drug manufacturer Eugia SEZ Private Limited’s February FDA inspection resulted in a Form 483 laden with examples of the company failing to follow procedures to prevent microbiological contamination of its drug products among seven observations of other lapses. Read More
Stool for Fecal Transplants Company Earns FDA Warning Letter
Teaser: The Warning Letter confirms that the organization must have an FDA-approved BLA confirming the product is safe, pure and potent. Read More
Human Microbes, a company promoting the value and sale of fecal microbiota transplants (FMT), has received an FDA Warning Letter listing a litany of regulatory violations, including lack of an FDA-approved BLA. Read More
The letter to Delsam says that it contracts with Global Pharma Healthcare Private Limited, a UK-based contract manufacturer, for its products. Read More
The FDA has issued warning letters to three eye drop manufacturers as part of ongoing investigations into a multi-state outbreak of more than 80 antibiotic-resistant eye infections that have led to four patient deaths and at least 14 cases of vision loss. Read More
Chinese pharmaceutical company Sichuan Deebio Pharmaceutical has suspended manufacture of at least one active pharmaceutical ingredient bound for the U.S. marketplace and may be banned from importation altogether if it doesn’t correct multiple deficiencies cited in a scathing 483 inspection report, according to a warning letter issued earlier this month. Read More