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The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Read More
The FDA blasted Kolmar Korea for failures to investigate out-of-specification test results and to follow standard operating procedures after a September inspection of its Sejong City facility. Read More
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Read More
The FDA blasted Kolmar Korea for failures to investigate out-of-specification test results and to follow standard operating procedures after a September inspection of its Sejong City facility. Read More
The FDA hit OTC oral gel manufacturer Europharma Concepts with a warning letter after finding significant CGMP violations at its facility in Clara, Ireland. Read More
The FDA observed multiple deficiencies related to equipment and quality control during a November inspection of Douglas Manufacturing’s finished drug facility in Lincoln, Auckland. Read More
The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility. Read More