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Procedures for finished device acceptance, design control and acceptance activities for contract manufacturers were not in place, the agency said. Read More
An FDA inspection of Highland Industries’ Cheraw, South Carolina facility uncovered numerous quality system deficiencies including missing validation and manufacturing records and test reports, along with a slew of other documentation failures. Read More
Failure to validate design under defining conditions, poor documentation and failure to evaluate complaints were a few of the deficiencies observed during an FDA inspection of surgical lighting manufacturer Sunnex’s Charlotte, North Carolina facility. Read More