The FDA cited Q A Laboratories after a lengthy inspection of its of Kansas City, Missouri facility revealed serious sanitation deficiencies and other nonconformances.
In an inspection in March and April, a team of five agency investigators discovered numerous sanitation issues that involved vermin infestations. In the facility’s raw material warehouse, they observed live and dead cockroaches, multiple small flying insects and pellet droppings “too numerous to count” on shelves, pallets, floors and areas near raw material containers.
They also found water leaking directly onto raw materials and mold-like discoloration on the product and warehouse walls. In addition, the warehouse had numerous openings, gaps and exposed pipes in its interior walls, as well as exposed pipes in the ceiling above raw materials and active pharmaceutical ingredients. Some materials were stored on the floor and large spring-loaded rodent traps were found in the room, which had excessive moisture and leaking water, while multiple raw material containers had sticky oily substances of unknown material.
A separate warehouse also contained rodent-like excretions, leaking water, insects and uncovered drains. Visible water puddling was found in front of the production room door and a dog was seen in the warehouse throughout the inspection.
The production room had similar violations. The investigators found more pellets, flying insects and fly tape covered with more than twenty small flying insects. More holes were found in the interior walls, along with a cut out opening in the walls with an unsecured plastic covering above the room doors.
The agency also cited the firm for failing to properly clean and maintain equipment including its manufacturing tanks. For example, the inside of one tank contained four to six inches of visible rust and more than fifty excrement pellets were found on top of a blender.