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Investigators found that the facility’s design validation procedures did not include a requirement to demonstrate equivalency to the production units. Read More
The FDA issued 483s to three device facilities for a variety of deficiencies including design control procedures, data integrity, CAPAs and complaint handling. Read More
Not only was equipment found to be out of calibration at All Quality & Services’ Fremont, Calif. facility, but the contract device manufacturer failed to document remedial actions, CAPA activities or investigate complaints, a January to February FDA inspection found. Read More
A January inspection of Gallaway, Tennessee-based device manufacturer Medegen Medical Products by the FDA uncovered a range of quality system failures, including a serious lack of process controls for which the firm received a 13-item Form 483. Read More
The firm failed to document corrective and preventive actions and failed to open a CAPA after being notified by a third party audit that the multimeters used to measure the voltage of the main board were not calibrated. Read More
A January inspection of Gallaway, Tennessee-based device manufacturer Medegen Medical Products by the FDA uncovered a range of quality system failures, including a serious lack of process controls for which the firm received a 13-item Form 483. Read More
The FDA cited Abbott Diabetes Care for inadequate complaint evaluation procedures following a November to December 2017 inspection of its Alameda, California, facility. Read More
During an inspection of the Medical Acoustics facility in Clarence, NY facility in December 2017, FDA investigators found that the firm failed to properly implement CAPA procedures. Read More
The FDA uncovered serious complaint handling and CAPA deficiencies during an inspection of Alpha Source’s Milwaukee, Wisconsin facility from Jan. 17 to Feb. 2 and handed the firm an eight-item Form 483 at the close of the inspection. Read More
An FDA inspection of Southwest Technologies’ Kansas City, Missouri-based facility in February and March uncovered 13 observations, most relating to quality system failures and failure to track nonconforming products and submit Medical Device Reports. Read More