Dimensional Merchandising Inc DBA: DMI Personal Care – FDA 483, Apr 18, 2023

Dimensional Merchandising Inc DBA: DMI Personal Care, a contract OTC drug manufacturer in Wharton, NJ, received a Form 483 with four observations. The inspection revealed deficiencies including inadequate identity testing for raw materials, insufficient controls over computer systems to prevent data alteration, failure to conduct annual visual examinations of reserve samples, and a lack of written procedures for equipment cleaning and preventative maintenance. These issues indicate significant concerns regarding quality control and data integrity in their manufacturing processes.