Montgomery Laboratories, LLC – FDA EIR, Sep 21, 2016

An FDA inspection of Montgomery Laboratories, Inc., a food additive manufacturer in Berwick, PA, was conducted on September 21, 2016. The inspection, carried out under the Domestic Food Safety Compliance Program, identified two primary concerns detailed on Form FDA 483, highlighting areas needing improvement in adherence to good manufacturing practices. The first observation noted issues with equipment and utensil design and materials that prevented proper cleaning. This included the use of cardboard to cover an opening in a sifter and a scoop repaired with duck tape. Such materials are not suitable for food contact surfaces. The second observation focused on the facility's sanitary conditions, particularly in the warehouse where ingredients were stored. Inspectors found personal items, an RV, and old equipment covered in dust, cobwebs, and spiderwebs in proximity to ingredients, creating an unsanitary environment and posing a potential risk of contamination. Company President and Owner, Paul J. Mangini, discussed the findings with the inspectors and committed to corrective actions. These included replacing the non-compliant cardboard with a suitable, cleanable material, removing the duck-taped scoop from service, and relocating non-essential items to a separate area to facilitate proper cleaning and pest control. Mr. Mangini also promised to address other discussed points such as sealing a door gap, smoothing rough welds on another scoop, ensuring all batch and training records were fully completed, and formally incorporating the recall plan into the company's Standard Operating Procedures. Management provided assurances that all identified issues would be resolved within two months.