At times no matter how well an organization plans, develops, or trains it people, or how focused it is on maintaining the best and most up-to-date controlled processes, the need for an intensive corrective action is necessary. In these cases, administrative oversight and approval is needed to assure that the corrective action plan meets all the needs of the organization and perhaps satisfies the regulatory oversight in place.
LDT has a broad experience in the formulation of custom POCs to address State Board, FDA form 483 deficiencies, and responses to FDA Waring Letters and other agency correspondence. LDT maintains the largest private database of FDA public documents relating to compounding in the nation. We can mine this data to provide trending and focused reporting to assist your organization in formulating the most efficient and coherent remediation plans.
At critical times like these let LDT partner with your organization to bring it expertise in regulatory and administrative procedures to assist you in this process. We specialize in developing time-critical action plans to address these types of situations. Let LDT join your legal, administrative, and operational team to assure that your response plan is measured, appropriate, and timely.