Numerous Procedural Violations Leads to Form 483 for Hoggan Scientific

Hoggan Scientific LLC has been hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues.

Hoggan’s Salt Lake City, Utah, facility was inspected in January and investigators discovered the manufacturer of diagnostic and measurement products failed to maintain several design control elements for its microFET 2 dynamometer; including a design development plan; inputs and outputs; review; verification and validation; and transfer.

Investigators also pointed out that Hoggan had not established procedures for analyzing quality data, investigating the cause of product nonconformities; and identifying; verifying; and implementing corrective and preventive actions.