FDA EIR - Nutra-Med Packaging Inc. - July 17, 2018

Nutra-med Packaging Inc. underwent an FDA pre-approval inspection from July 16-17, 2018, in Whippany, NJ. The inspection was conducted under the Compliance Program Guidance Manual for Drug Pre-approval Inspections, focusing on the firm's primary packaging operations for an Abbreviated New Drug Application (ANDA) and its general quality system for pharmaceutical and dietary supplement packaging.

Overall, the inspection found no significant deficiencies in the firm's quality system, and no FDA Form 483, Inspectional Observations, was issued. Investigators reviewed the ANDA's proposed commercial packaging records, equipment qualification, and personnel training, noting no discrepancies and recommending approval for the ANDA.

Additionally, the inspection covered a Field Alert related to an empty carton incident for a product packaged by Nutra-med. The firm's investigation identified the root cause as a weight checker air nozzle system that lacked sufficient force to reject empty cartons. Proactive corrective actions included replacing the nozzle system with a more effective ejection mechanism and increasing the frequency of weight checker challenges. A 100% re-inspection of relevant on-site product lots found no further issues. The inspection concluded without any regulatory violations requiring formal action.