QUALITY NUTRITION LABS – FDA EIR, Apr 22, 2021

An FDA inspection of QUALITY NUTRITION LABS, a contract packer and labeler of dietary supplements, was conducted from April 21-22, 2021. This initial inspection, performed under compliance programs for dietary supplements, did not result in an FDA Form 483, but several observations were discussed with management for corrective action. Main issues identified included deficiencies in the firm's Master Manufacturing Records (MMRs). Specifically, MMRs did not consistently reflect variations in neck band sizes used during bottling with different equipment, nor did they contain a representative product label or a reference to its physical location. Additionally, the firm's cleaning logs were not being reviewed and signed within the required timeframe, and an automatic towel dispenser in the women's restroom was found to be non-functional. In response, management committed to updating relevant MMRs to document neck band variations within one week and to include representative labels or references within three weeks. They also agreed to immediately implement proper review and signing procedures for cleaning logs. The faulty towel dispenser was undergoing repairs, expected to be completed by April 26, 2021.