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The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More
The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
Another compounding pharmacy has received an FDA warning for actions that occurred prior to passage of a new law that boosted the agency’s authority over such facilities. Read More
A Form 483 describes the quality problems that led the FDA to ban imports from Ranbaxy’s Toansa, India plant, with investigators troubled by workers retesting samples until they get acceptable results. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
The FDA has warned another compounding pharmacy for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for “significant deviations” of current good manufacturing practices (cGMPs), including failures to ensure adequate environmental monitoring and employee training. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More