An FDA inspection is not a matter of if, but a when, for life sciences companies. Especially organizations manufacturing Class II or Class II devices, pharmaceuticals, and other regulated products, can expect to have FDA regularly show up for an audit. Unfortunately, not every audit goes without a hitch, and some companies might receive a Form 483 observation or a warning letter.

An FDA form 483 observation, also known as an inspectional observation, is a notice sent by the FDA to inform an organization of potential facility, equipment, processes, controls, products, employee practices, or records violations found during a routine audit. The most common causes of a Form 483 observation are procedures not fully followed, poor investigations of discrepancies or failures (CAPA process not used) and the absence of written procedures. A form 483 observation can be very costly and trigger need for new training, redesign, process implementation, and other measures.

What happens after you receive a Form 483 observation? The first step should be to request to go over the document with the FDA inspector to get a better understanding of their concerns. Once the organization has processed the results, you are obligated to submit a written response within 15 days demonstrating that the observed problems have been handled. Failure to do so could result in the Form 483 observation being escalated to a formal warning letter.

An FDA warning letter is a formal notification from the FDA that notifies an organization of serious violations. This formal letter is issued by more senior officials after having reviewed the inspector’s reports and is commonly caused by non-compliance with written procedures, failure to follow written procedures and failure to prove that regulations have been followed with adequate documentation. Warning letters are delivered in person and require a written response 15 days within being received. In addition to a written response, organizations are legally required to make any changes necessary to satisfy the FDA’s concerns. Unlike Form 483 observation, warning letters are made public and could be accessed by competitors and stakeholders.

While an organization is not legally required to take action when faced with a Form 483 observation, not doing so could result in a warning letter that would force the organization to publicly take responsibility for regulation violations. It’s also possible to receive these two kinds of warnings at the same time depending on the severity of the violations. It is crucial to always be audit ready and act promptly at the face of a From 483 observation, as a formal warning letter could be a major financial and reputational burden on an organization. Reach out to Precision Life Sciences, a division of Precision Talent Group to learn more.