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FDA investigators observed multiple deficiencies during an October 2020 inspection of B. Braun Medical’s sterile IV fluids facility in Daytona Beach, Florida. Read More
Ascent Pharmaceuticals, a drug manufacturer in Central Islip, New York, drew a Form 483 after the FDA observed deficiencies at its facility, including a failure to check the effectiveness of corrective and preventive actions (CAPAs). Read More
FDA inspections revealed good manufacturing practice and other deficiencies at drug manufacturing facilities in New Jersey, Vermont and California, leading to Form 483 inspection observations for four firms. Read More
A Florida manufacturer of over-the-counter drug products had high microbial counts in water it used for manufacturing among other significant violations of current good manufacturing practice, according to an FDA warning letter to the firm. Read More
An FDA investigator observed quality lapses during an inspection of Fairfield, New Jersey generic and over-the-counter drugmaker AACE Pharmaceuticals, including sticky tape on equipment used to produce drug products. Read More
A Florida manufacturer of over-the-counter drug products had high microbial counts in water it used for manufacturing, among other significant violations of current good manufacturing practice, according to an FDA warning letter to the firm. Read More
Kobo Products, a South Plainfield, New Jersey drug manufacturer drew a Form 483 from the FDA detailing six issues observed during an August inspection. Read More
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