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The FDA hit N-Molecular, doing business as SOFIE, with a warning letter after an inspection of the company’s positron emission tomography (PET) drug manufacturing facility in Haverhill, Mass., brought to light numerous hygiene violations. Read More
The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Read More
The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert Friday and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure products. Read More
The agency also found that the firm’s drug products — which were expected to be sterile — were adulterated as they had been exposed to conditions that may have led to contamination. Read More
Symed Labs was hit with a Form 483 after an FDA inspection of its Hyderabad, Telangana facility revealed equipment cleaning and complaint handling violations. Read More
The FDA slapped Phoenix-based outsourcing facility Atlas Pharmaceuticals with a warning letter for adulterated and misbranded drug products as well as numerous CGMP violations stemming from an inspection carried out in August and September 2017. Read More