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Fourteen days of FDA inspection of its New Brunswick, N.J., facility in February and March earned Spectrum Laboratory Products a 483 describing yellow streaks on floors, peeling paint on walls and only 58 of 5,679 complaints investigated, among the 14 observations in the FDA’s report. Read More
The FDA has issued two draft guidances focused on requirements for drug and biological approvals — one on formal meetings and one on alternative methods the agency may use to assess manufacturing facilities named in an NDA or BLA. Read More
A mix up that put a vitamin in a blister pack where a drug to prevent organ transplant rejection belonged is one of several violations the FDA cited in its warning letter to Safecor, a Columbus, Ohio, drug manufacturer and repackaging company. Read More
The FDA has issued warning letters to eight companies — including CVS Health and Walgreens Boots Alliance — for manufacturing or marketing illegal, unapproved eye drops to treat pink eye, glaucoma and cataracts and other ophthalmic conditions. Read More
The FDA has exercised its new authority to use remote records reviews in lieu of certain types of GMP inspections, issuing a warning letter to Green Pharmaceutical of South Korea based on a review of records it requested on March 3. Read More
Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More
A July 10-20 FDA inspection of a Biocon manufacturing facility in Malaysia turned up eight observations including a repeat observation of failure to follow procedures that prevent microbiological contamination of drugs intended to be sterile, and inadequate review and investigation of failed batches. Read More
The FDA’s efforts to safeguard against the presence of diethylene glycol (DEG) ethylene glycol (EG) in drug products have resulted in the agency issuing 22 warning letters on the potentially lethal contaminant since March — and nine on the issue just this week. Read More
The FDA slapped Iso-Tex with a Form 483 following a Jan. 30 – Feb. 10 inspection because the radiopharmaceutical manufacturer failed to prevent microbiological contamination of drug products at its Alvin, Tex., plant. Read More