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Baxter subsidiary Claris Injectables was hit with a warning letter for significant water damage, falsely recording data and neglecting to properly investigate out-of-specification results at its Ahmedabad, Gujarat facility. Read More
The FDA cited Q A Laboratories after a lengthy inspection of its of Kansas City, Missouri facility revealed serious sanitation deficiencies and other nonconformances. Read More
The FDA cited Pfizer’s Hospira manufacturing facility in Sriperumbudur, Tamil Nadu for a slew of repeat deficiencies, including falsifying data, in a Form 483 flagged as Official Action Indicated – indicating that the agency is planning further enforcement action against the company within six months. Read More
The FDA issued a warning letter to Zhuhai United Laboratories, an active pharmaceutical ingredient firm based in Zhuhai, China, taking the facility to task for failure to investigate out-of-specification results and correct critical CGMP deviations. Read More
The FDA hit Product Packaging West, an OTC drug manufacturer in Hollywood, California, with a Form 483 after an inspection revealed deficiencies with its purified water system, cleaning procedures and equipment calibration. Read More
FDA investigators also observed personnel failing to disinfect materials before entering the aseptic processing areas after handling them with bare hands. Read More
In a follow-up inspection to a March 2017 warning letter, the FDA issued a Form 483 to Ranier’s Compounding Laboratory, accompanied by a public safety alert warning healthcare professionals and patients not to use the facility’s products purporting to be sterile. Read More
The FDA issued a warning letter to Zhuhai United Laboratories, an active pharmaceutical ingredient firm based in Zhuhai, China, taking the facility to task for failure to investigate out-of-specification results and correct critical CGMP deviations. Read More
The FDA hit Product Packaging West, an OTC drug manufacturer in Hollywood, California, with a Form 483 after an inspection revealed deficiencies with its purified water system, cleaning procedures and equipment calibration. Read More