FDA EIR - Lab Ofichem B.V. - September 18, 2019

An FDA inspection of Lab Ofichem B.V., an Active Pharmaceutical Ingredient (API) manufacturer located at Heembadweg 5 Ter Apel, was conducted from September 16 to September 18, 2019. This surveillance GMP inspection was part of CDER FY19 operations and followed the regulatory framework of CP 7356.002F, "Active Pharmaceutical Ingredient (API) Process Inspections," with guidance from ICH Q7A. The inspection covered critical areas including Production, Quality, Laboratory Control, Materials, and Facilities and Equipment Systems for the firm's non-sterile API production. Significantly, no FORM FDA 483 was issued following the inspection, indicating an absence of significant objectionable conditions. However, six verbal observations were discussed with the company's management team during a closeout meeting on September 18, 2019. These observations did not warrant formal regulatory action. Consequently, the inspection was classified as "No Action Indicated" (NAI), signifying that the FDA found no conditions requiring an official response or enforcement. No samples were collected, and no refusals were encountered during the process. The report concludes with a recommendation to re-inspect the facility as per the ongoing work plan.