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Owen Biosciences, an over-the-counter drug manufacturer in Baton Rouge, La., drew a Form 483 inspection report from the FDA detailing observations about good manufacturing practices at the company’s facility. Read More
An FDA inspection of Romark Global Pharma’s Manati, Puerto Rico drug manufacturing facility revealed problems with contamination of drug products and equipment. Read More
UCSF Radiopharmaceutical Facility drew a lengthy inspection report from the FDA for failing to fully investigate out-of-specification results and other quality lapses. Read More
Pro Breath MD and Vibrant Health Care: The FDA has issued a flood of warning letters during the pandemic to crack down on marketers of sham COVID-19 treatments. Read More
A Vermont-based over the counter (OTC) skincare company Twincraft developed certain “written production and control procedures to include batches formulated with the intent to provide less than 100 percent of the labeled or established amount of active ingredient,” an FDA investigator found during an Aug. 18-25 inspection. Read More
Generic drugmaker Aurolife Pharma received an FDA warning letter for water leakage in its plant that affected batches of medicine, powder residue on surfaces that were supposed to have been cleaned, and impurities in a batch of medication. Read More
Merck announced yesterday that it is discontinuing its phase 3 nonsmall-cell lung cancer trial of Keytruda (pembrolizumab) in combination with Bristol Myers Squibb’s (BMS) Yervoy (ipilimumab), citing an unfavorable benefit-risk profile. Read More
An FDA inspection of Romark Global Pharma’s Manati, Puerto Rico drug manufacturing facility revealed problems with contamination of drug products and equipment. Read More
The FDA issued warning letters to four topical drug manufacturers in Mexico for using unapproved ingredients in their hand sanitizer products. Read More
FDA investigators cited five drug facilities for failures ranging from late field reports to lax control of data, complaint handling and training. Read More