Propose a response letter for Signature Biologics, LLC - 631039 - 09/18/2023 | FDA Warning Letter. In the response letter, restate each observation, and address each observation individually and completely, including a due date for completion, short-term and long-term solutions where necessary, and a means to determine corrective action effectiveness. (If, for example, implementing a new document management system is the proposed corrective action, that would be a long-term solution, as it would take a significant amount of time to research, select, purchase, install, and validate the system). That is fine, but also expecting that some short-term interim controls to deal with the observation until the long-term solution is operational, could be included. Other robust solutions, such as updating a SOP, can be done quickly, and may be completed at the time the response letter is written.) Realistic thoughts or responses and solutions. Assessing whether the specific problem cited impacts batches that have already been distributed/staged for distribution in the warehouse; what actions are necessary to protect patients?