The following 483 describes an organization denying FDA Investigators entry into a warehouse storing APIs, leading to harsh regulatory consequences.
United States law permits FDA Investigators to enter and inspect a facility, so this observation is an obvious mistake.
However, on a deeper level, there are implications that we would like to discuss, pertaining to the importance of imbuing quality into all aspects and actions of an organization.
The warehouse managers should not have been fearful to permit a walkthrough of the facility because they should have been conducting all operations with a quality mindset.
Great product quality requires everyone in an organization to value product safety from start to finish in every single action.
As Quality Leaders, you spearhead these quality efforts. We see you, we recognize you, and we thank you for ensuring great product quality and protecting public health.
The 483 reads:
…..Access to the warehouse storing APIs, Intermediates, and key starling materials (KSMs) intended for the US market and its associated records were not made readily available for inspection.
Specifically, upon arrival for inspection, entry was denied for approximately two (2) hours to inspect the warehouse that holds key starting materials. Intermediates and finished APIs for US FDA registered manufacturing facilities that routinely distribute to the U.S market and to facilities that manufacture finished drug products for the U.S. For example:
a. The warehouse gates for both buildings were wide open upon arrival and appeared to store multiple drums and bags of product. We displayed our U.S FDA credentials to the two (2) security officers present and explained our intent to conduct a walkthrough of the warehouse. However, we were immediately refused entry into the warehouse which includes two buildings. In addition, employee personnel, who were later identified as the Assistant Warehouse Manager and Warehouse Staff, had run out of plain sight upon announcing our intent to inspect the facility. The warehouse gates were then lowered and completely shut on all sides until approximately two (2) hours after arrival.
b. Upon arrival for inspection, a truck full of drums was stationed at the warehouse loading dock. We explained our intent to inspect the truck but were refused to do so. The truck full of drums had left the facility without any explanation provided. In addition, another incoming truck was turned away by the security officers upon their indicating our presence at the facility.
