Innova SoftGel LLC – FDA EIR, Apr 5, 2016

An FDA inspection of Innova Softgel, LLC, a manufacturer of dietary supplements and cosmetics in Miami, Florida, was conducted from March 21 to April 5, 2016. The inspection primarily focused on dietary supplements, regulated under Current Good Manufacturing Practices (CGMP) as per Compliance Program #7321.008. This inspection followed a March 2014 review that identified numerous violations and resulted in an Official Action Indicated (OAI) classification, including issues with quality control, manufacturing processes, and complaint handling.

The current inspection revealed two main issues documented on a Form FDA 483. First, Innova Softgel failed to establish and consistently follow written procedures for reviewing and investigating product complaints. Specific concerns included complaints not being closed within defined timeframes and delays in formal recognition of received complaints. Additionally, the firm lacked formalized Quality Agreements with its bulk dietary supplement customers, which would outline responsibilities for complaint notification. Second, laboratory test and examination documentation was incomplete, not including full results. Mr. Georg Reiser, the General Manager, committed to making necessary corrections and providing a written response to the FDA within 15 working days.