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Contract manufacturer Thatcher Company failed to exercise appropriate controls over computers and related systems to assure that changes in production were only instituted by authorized personnel, FDA inspectors found during a Sept. 10 to Sept. 18 inspection of the firm’s Salt Lake City, Utah, facility. Read More
Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual Properties’ Irvine, Calif. facility. Read More
FDA inspectors found shoddy process controls and a lack of validation documentation in a Sept. 17 to Sept. 21 inspection of Footprint Medical’s San Antonio, Texas facility. Read More
The firm was also called out for device history records, which lacked identification labels and labeling, and its reviews of document control procedures. Read More
The firm also didn’t document, on either return goods authorization forms or verbal complaint forms, if it evaluated the complaint to see if it should be reported to the FDA as part of medical device reporting. Read More
The FDA hit Monmouth Junction, New Jersey device manufacturer Replication Medical with a Form 483 following an inspection that revealed issues with the firm’s documentation of corrective and preventive action activities and device history records. Read More
A 12-item 483 documents a litany of quality system failures the FDA found at Diasol East of Watertown, Tenn., during an Aug. 7 to Aug. 22 inspection. Read More