FDA 483 - Creative Testing Solutions - July 25, 2008

This FDA Form 483 document details an inspection observation regarding the facility's adherence to written standard operating procedures (SOPs) for processing blood and blood components for homologous transfusion. The core issue identified is the inconsistent maintenance of these SOPs, specifically concerning the development of Corrective and Preventive Actions (CAPs).

The document states that formal CAPs are required for all trends, including those associated with "REDACTED" and "REDACTED" investigations. However, the inspection revealed that several "REDACTED" investigations lacked an attached formal CAP. Two specific examples cited were exceptions "REDACTED" and "REDACTED," both categorized as "REDACTED" problems. While the facility's "REDACTED" policy allows for exceptions in specific cases for historical trends unrelated to these examples, it does not permit "REDACTED" problems to be closed without a formal CAP. This indicates a deficiency in the quality system's handling of investigations and the implementation of corrective actions, potentially impacting the overall quality and safety of blood and blood components.