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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
One of the firm’s gauges measuring differential pressure between its ISO 8 anteroom and an unclassified area had a reading of zero, the agency said. Read More
The firm’s ISO 7 cleanroom also contained items that were complicated to clean, such as a computer keyboard, a hand-held calculator and many pieces of particle-generating paper. Read More
The FDA hit Guadalajara, Jalisco-based drug manufacturer Jabones y Productos Especializados (Soaps and Specialized Products) with a Form 483 for multiple violations, including serious quality deficiencies, observed during a March 20-23 inspection. Read More