Services

Types of services include:

• Identify requirements for importing FDA regulated products into the U.S. market

• Evaluate FDA notices for import holds, detentions and refusals

• Identify practical strategies to respond to FDA import detentions and refusals based on FDA Import Alerts and FDA sample collections

• Identify FDA pre-market requirements for entering specific products into the U.S. market

• Review records, products, and labeling to determine FDA compliance status

• Evaluate FDA Inspectional Observation (FD483) reports

• Review and evaluate standard operating procedures designed to implement FDA good manufacturing practice regulations

• Assist with the development of requirements for software and programs designed to determine the potential risk of FDA regulated commodities and related international supply chains

• Assist with the development Freedom of Information Requests (FOIAs) by identifying location and types of information maintained by FDA relevant to a business' or organization's project area

• Provide customized training on FDA import operations, procedures, policies, authorities, good manufacturing practices and other technical areas as needed