FDA EIR - Medolac Laboratories, A Public Benefit Corporation - April 04, 2019

An FDA inspection of Medolac Laboratories, A Public Benefit Corporation, a human breast milk manufacturer in Boulder City, NV, was conducted from April 2 to April 4, 2019. This follow-up inspection, initiated by a consumer complaint, assessed compliance with the Domestic Low Acid Canned Food (LACF) and Preventive Controls in Human Foods (PCHF) regulatory frameworks. Notably, no formal inspectional observations (FDA Form 483) were issued.

However, four key areas were discussed with management for improvement. The firm was advised to enhance its risk-based hazard analysis to clearly identify biological, chemical, and process-related hazards for each ingredient and processing step. Additionally, while the company demonstrated strong supplier qualification and raw material testing, it lacked a formal written supply-chain program. Minor concerns included a water backsplash during cleaning affecting nearby utensils, and recommendations for better documentation practices, such as consistent employee initials on manufacturing records and including equipment numbers on cleaning checklists.

Medolac's management committed to these actions, agreeing to update the hazard analysis within six months and establish a written supply-chain program by August 2019. The cleaning and documentation issues will be addressed in ongoing employee training, with a cleaning checklist already updated during the inspection. The inspection found no evidence supporting the consumer complaint's allegations regarding unsanitary conditions or pest infestation.