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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
The inspection revealed that drug products intended for distribution weren’t adequately tested to show that their active ingredients’ identity and strength met final specifications. Read More
The FDA hit South Korean drugmaker Hanlim Pharma with a warning letter for current GMP and other deficiencies observed during an inspection of its OTC manufacturing facility in Gyeonggi-do province earlier this year. Read More
The FDA flagged deficiencies in corrective actions, testing and documentation during a July/August inspection of UK drug substance and sterile drugmaker Porton Biopharma. Read More
The facility received complaints about particulate matter or cloudiness in its Potassium Chloride Oral Solution, but it continued to manufacture and distribute it. Read More
The FDA flagged South Korean drug manufacturer EEJE for quality and testing deficiencies observed during a July 30 to Aug. 2 inspection of its facility in Gyeongsangnam-do province. Read More