Upon receiving a warning letter from FDA for mislabeling, a regulatory affairs professional should first contact which entity?

When a regulatory affairs professional receives a warning letter from the FDA for mislabeling, the first action they should take is to contact the Compliance Branch in their district. This choice is correct because the Compliance Branch is responsible for managing regulatory compliance matters at the local level, ensuring that manufacturers adhere to the laws and regulations set by the FDA. By initiating communication with this branch, the professional can better understand the issues raised in the warning letter, seek clarification on compliance expectations, and discuss potential corrective actions.

Communicating with the Compliance Branch is crucial for effectively addressing the FDA's concerns and developing an appropriate response strategy. It also allows the organization to demonstrate its commitment to compliance and willingness to rectify labeling issues.

The other options, while relevant in other contexts, are not the appropriate first contacts in this situation. The Orthopedic Branch Chief in the CDRH Office of Device Evaluation would typically handle issues relating to specific device evaluations rather than compliance concerns. The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) primarily assists small manufacturers with regulatory and guidance questions, which may not be the best point of contact for specific compliance warning issues. The CDRH Ombudsman focuses on resolving disputes and communication issues within the FDA but is not the first resource to address