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Drug manufacturer Degasa did not adequately test its products or include all necessary data in laboratory records, according to a warning letter from the FDA. Read More
The FDA issued a warning letter to McCallum Manufacturing for deficiencies in process validation and quality control after an inspection of the firm’s Barnsley, South Yorkshire facility. Read More
The FDA hit Optikem with a Form 483 after the agency’s investigator observed unsanitary conditions and problems with records in an inspection of the firm’s Denver facility. Read More
In its first required inspection metrics report for 2017, FDA officials found a median time of 102 days between inspection requests by the FDA to a facility and the beginning of inspections, and a median of seven days between the beginning of a pre-approval inspection and the issuance of a Form 483. Read More
The FDA warning letter asked the company to describe its corrective action plan and testing procedures to ensure all product batches are tested for identity and strength before being sent to the United States. Read More
The FDA issued a warning letter to McCallum Manufacturing for deficiencies in process validation and quality control after an inspection of the firm’s Barnsley, South Yorkshire facility. Read More
The FDA hit Optikem with a Form 483 after the agency’s investigator observed unsanitary conditions and problems with records in an inspection of the firm’s Denver facility. Read More
The FDA warned Tris Pharma for manufacturing adulterated products at its Monmouth Junction, New Jersey facility, citing failures to properly investigate product defects and other deficiencies found during a March inspection. Read More
The FDA cited API manufacturer CIL Isotope Separations after an inspection of its Xenia, Ohio facility revealed quality control issues, investigational deficiencies and other violations. Read More