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The firm attributed out-of-specification and out-of-trend assay results for certain tablets to sampling preparation errors but didn’t provide any evidence to support the findings. Read More
The FDA sent a warning letter to Apotex Research after discovering significant and repeat violations at its Bangalore facility that led to adulterated finished drug products. Read More
On several occasions after removing jams the operator leaned inside the restricted access barrier system to clean the equipment, the agency said. Read More
An FDA inspection of Korean sterile OTC drug manufacturer Hanlim Pharm in January turned up multiple failures to follow procedures for preventing product contamination. Read More
In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections in 2016 and 2017. Read More
The FDA sent a warning letter to Connecticut-based drugmaker Milbar Laboratories for quality deficiencies and failure to investigate out-of-specification batches. Read More
A Celltrion plant based in Incheon City, South Korea, was hit again by the FDA for violations observed during an inspection last month following a February warning letter. 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 to correct critical CGMP deviations. Read More
The FDA said the company failed to explain why it distributed the contaminated lots or to address the need for improvements in its quality system. Read More
The FDA sent a warning letter to Connecticut-based drugmaker Milbar Laboratories for quality deficiencies and failure to investigate out-of-specification batches. Read More
The FDA issued Form 483s to U.S. and foreign drugmakers, citing violations for sanitation issues, unreliable data and nonconformances, among other observations. Read More