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
Enteromedics drew a Form 483 from the FDA for producing printed circuit boards using a non-validated process, not identifying defective circuits and incorporating the nonconforming boards into its devices. Read More
The FDA handed Endotec a Form 483 after a December inspection of its Santa Fe Springs, California facility brought to light validation failures and corrective and preventive action shortcomings. Read More
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