Nutra-Med Packaging Inc. – FDA EIR, May 3, 2018

A Pre-Approval inspection of Nutra-med Packaging Inc., a pharmaceutical and dietary supplement packer and repacker located in Whippany, NJ, was conducted by the FDA from May 2-3, 2018. The inspection, carried out under regulatory guidelines CPGM 7356.002 (Drug Manufacturing Inspections) and CPGM 7346.832 (Pre-Approval Inspections), specifically evaluated the facility's primary packaging operations for an Abbreviated New Drug Application (ANDA). The scope included a thorough review of the company's Quality, Facilities and Equipment, and Packaging and Labeling Systems. Additionally, the inspection verified the satisfactory correction of discussion points identified during a previous inspection in October 2016. The FDA investigator reported that no objectionable conditions were observed during the inspection. All reviewed procedures, equipment qualifications, batch records, and facility conditions, including storage areas and packaging lines, were found to be compliant. Consequently, no Form FDA 483, Inspectional Observations, was issued to Nutra-med Packaging Inc. As a result of the favorable inspection findings, recommendations for the ANDA approval were communicated to the Pre-Approval Manager, indicating that the facility meets the necessary standards for the proposed drug product packaging.