Consequences of Receiving an Observation in a Regulatory Audit/Inspection, Essay Example

Part I

When an audit/inspection is conducted within a facility, there is always a risk of a finding or other concern that requires further explanation and/or follow up. If an observation is made during an audit/inspection, the issue will be addressed with the responsible parties and is likely to require additional follow up and/or changes to existing practice methods. The consequences of observations may include written warnings regarding study protocols, partial or full study shutdown, potential adverse events, lower patient enrollment, and lack of follow through for patients already recruited.

When observations are minor, small yet important modifications must be addressed to prevent adverse events or other concerns. This may include small changes to the study protocol, increased follow up visits for patients, or a modification to the data collection process. These concerns are often managed effectively without significant delays or other complications that may harm the overall integrity of the study protocol.

When observations are major, there is a much greater risk to subjects; therefore, the existing protocol may require significant changes to reduce these risks and to prevent unnecessary harm to patients. This includes the observation of one or more adverse events, a significant risk to subjects at any given phase of the study, and a change in drug quality or manufacturing processes that may pose a risk to patients. These conditions pose a serious threat to the integrity of the study and its outcomes.

When observations are critical, there is a clear issue of study credibility and a much greater risk of harm to patients. This includes the issues associated with adverse events that lead to the death of a patient, events that lead to serious complications such as stroke, coma, or incapacitation, and the administration of inappropriate dosages that lead to serious complications.

Part II

In preparation for FDA-level inspections, facilities must demonstrate their knowledge of GLP regulations and the influence of their studies on patient care and wellbeing. This is critical in supporting the development of new perspectives and approaches to improve preparation efforts prior to inspections, whether they are routine or are a surprise. When the FDA arrives for an inspection, there is a standard protocol that must be followed when working with the facility in order to promote efficiency and ease in conducting the inspection in accordance with GLP regulations. These steps include an examination of the facility’s floor plan, its organization charts, its SOPs, and its equipment maintenance protocols. Each of these areas is critical to inspection efforts and the development of conclusions regarding the inspection and the state of the facility. In addition, it is necessary to establish a greater understanding of the potential impact of inspections on the facility and its future operations.

The FDA report may include a written segment that emphasizes the key findings and variables to consider that may require immediate action. In addition, verbal comments may be provided from which the facility makes any required changes. In the follow up phase, the FDA may conduct a meeting with the facility in order to determine how to resolve any findings and to move forward with additional protocols as necessary. An example involving Pfizer and its deficiencies demonstrates that the organization lacked follow through and did not take the required steps to rectify their weaknesses after the FDA inspection. This was a serious violation because the FDA could not be certain that the organization could conduct itself according to GLP standards in the months after the inspection had taken place. Therefore, the organization placed itself at significant risk for serious failure in this area.

Part III

A warning letter issued by the FDA must be taken very seriously because it provides a summary of the actions or lack thereof conducted by a facility that may lead to serious complications. When a facility fails to comply with basic GLP regulations and poses a potential risk to its patients, it is necessary to consider that warning letters from the FDA are critical and pose a serious threat to an organization’s integrity and livelihood. It is likely that when multiple findings are discovered and summarized in a warning letter, there is an even greater risk to the facility and require an immediate action plan. Therefore, facilities must accept these warnings and take them seriously in order to accomplish the desired objectives in a manner that is consistent with the protection of human subjects.

It is perhaps most important to take FDA warning letters seriously because if the findings that are discovered are not managed and resolved within a period of time, the facility’s entire operations may be shut down until these deficiencies are corrected. This is a serious consequence of a failure to exercise discretion and to provide the best possible quality control and assurance objectives for the facility and its activities. Under these conditions, there is a significant risk to the facility and its failure to adhere to GLP standards. As a result, warnings deemed significant by the FDA must be taken seriously and managed with a collaborative and comprehensive approach to correcting these findings in an effective manner. There are considerable challenges associated with FDA warning letters that must also be addressed by the facility by accepting deficiencies and establishing plans that will correct these deficiencies as best as possible to prevent additional warnings and other complications that could lead to a facility shutdown in the future.