Poor GMP/GDP Practice found in US Warehouse

Recommendation

6/7 November 2024

Ambient Transport and Cold Chain - Live Online Training
Temperature controlled Transports of Medicinal Products

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".