483
Daniels Manufacturing Operations IncDaniels Manufacturing Operations Inc – FDA 483, Nov 8, 2023
Record Details
Daniels Manufacturing Operations Inc, a contract manufacturer in Racine, WI, was cited for multiple deficiencies in its quality management system. The inspection revealed inadequate documentation of corrective and preventive actions, insufficient procedures for equipment calibration and maintenance, and a complete lack of quality audit procedures. Furthermore, management failed to conduct required reviews of the quality system and ensure the quality policy was understood by employees.
View Company Profile
ID · dfad89fc-b987-4359-b58e-7f6fa10e1060
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.