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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
The FDA placed Sichuan-based drugmaker Sichuan Friendly on an import alert after an October inspection of its facility in Neijiang City revealed stability and manufacturing issues with active pharmaceutical ingredients shipped to the U.S. Read More
A heavily staffed FDA inspection of pharmaceutical giant Mylan’s manufacturing facility in Morgantown, West Virginia netted the company a lengthy Form 483 listing numerous deficiencies in the firm’s quality control unit. Read More
The FDA placed Sichuan-based drugmaker Sichuan Friendly on an import alert after an October inspection of its facility in Neijiang City revealed stability and manufacturing issues with active pharmaceutical ingredients shipped to the U.S. Read More
The FDA hit Eau Zone Huiles Et Fragrances with a Form 483 after an inspection determined the OTC manufacturer had numerous deficiencies at its Montreal, Quebec facility including cleaning, testing and drug storage issues. Read More
The FDA cited Reliance Life Sciences for a long list of deficiencies observed during an inspection of the API manufacturer’s facility in Navi Mumbai in December. Read More
The FDA hit Surmasis Pharmaceutical of Des Moines, Iowa with a Form 483 after a February inspection revealed problems with laboratory records, computer systems and equipment inspections. Read More