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
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
The FDA cited Reliance Mobility in a Form 483 with 13 observations after an April inspection of the company’s Columbia, Tennessee, facility. Read More
Hand Biomechanics failed to complete package integrity validations and had incomplete medical device reporting procedures, the FDA said in a Form 483 issued after a March/April inspection of its Sacramento, California, facility. Read More
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