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The FDA issued a warning letter to United Exchange, a Cerritos, California-based drug manufacturer for filing inaccurate ingredient information for the National Drug Code (NDC) directory. Read More
Contract drugmaker Izeen Pharma of Frederick, Maryland, drew a 21-page Form 483 from the FDA for numerous deficiencies, including inadequate validations and poor data handling. Read More
Agency inspectors also observed serious CGMP violations during a June 13-29, 2017, inspection and noted that the facility failed to qualify for exemptions from FDA oversight under section 503B of the Food, Drug and Cosmetic Act. Read More
The FDA issued a warning to CustomRX of Wichita, Kansas, for serious deficiencies identified during an inspection of its compounding facility, including inadequate cleanroom conditions and product testing. Read More
In a rare warning letter from the FDA’s Office of Prescription Drug Promotion (OPDP), Vanda Pharmaceuticals was cited for failing to include any risk information on the product page of its website. Read More
The FDA hit drug manufacturer Oakmont Products of Lincoln, Nebraska, with a Form 483 for lacking a quality control unit, among other serious deficiencies. Read More
The FDA cited Holly Hill, Florida, manufacturer Tropical Seas following a May 21-30 inspection for inadequate training and poor facility maintenance. Read More
The FDA issued Berkshire Sterile Manufacturing a Form 483, citing issues encountered during an inspection at the firm’s Lee, Massachusetts, facility. Read More
The FDA hit Auro Pharmacies of La Habra, California, with a warning letter for unapproved and adulterated drugs and significant good manufacturing practice violations at its outsourcing facility. Read More