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Modal Manufacturing Cited for Design Analysis, Validation Issues
Devices Inspections and Audits
Modal Manufacturing landed a Form 483 from the FDA for problems with its procedures for ensuring all products it received from suppliers conformed to specification and for inadequate design risk analysis.
The FDA issued the form following a December 2017 inspection of its Palm Beach Gardens, Florida facility. Investigators found that four of the facility’s suppliers did not have any on-site audits as required by the company’s standard operating procedures.
Investigators also found the company conducted several processes that had not been properly validated.