New Jersey Contract Manufacturer Draws 483 for Quality System Failures
The FDA hit Parsippany, N.J. contract manufacturer Davion with a Form 483 after an inspection revealed failures regarding its quality system and facility management.
The agency inspected the production facility from May 7-10 and again on May 15 and found that the firm did not properly follow its quality control procedures.
Specifically, the agency noted, the firm failed to document changes it made to its medicated body powder product. The product drew an out of specification result for not meeting empty bottle weight specifications.