11/12 October 2022
Any contract giver is ultimately responsible for the product in the marketplace even where certain activities are contracted out. They are therefore responsible for defining appropriate controls in a clear written contract and monitor to ensure that the contract acceptor performs the outsourced activity as required. Audits should be undertaken at a frequency determined by the contract giver's risk assessment. If periodic audits of the contract acceptor are not frequent enough there is a risk that GMP and GDP standards slip without the contract giver being aware until a significant issue occurs.
What can go wrong for example in a warehouse was now published in a news release by the U.S. Food and Drug Administration FDA. In a warehouse in Arkansas, USA, which also stores and distributes over-the-counter (OTC) drugs obtained through brokers, observations were made beyond belief. The investigators found "alarming" insanitary conditions including "multiple live and dead rodents, rodent nesting, live raccoons, live cats, a dead possum, animal feces, and urine-stained products in and around the company's seven warehouses".
As a result, FDA issued two Administrative Detention Orders calling for the detention of all human and animal food products and drugs.
Source: FDA News Release "FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse".