What does the FDA require of various transportation companies?

• A. The FDA requires each company to keep records for all shipments regardless of involvement.
• B. When trucks and planes are owned by different companies, the FDA requires each company to keep records only of transactions to which it is a party.
• C. The FDA requires all parties to share a single universal record.
• D. The FDA requires no records for third-party logistics.

Answer: (B)

In this area, accountability along the supply chain is the key idea. When trucks and planes are operated by different companies, each party should keep records for the transactions it is directly responsible for. This means the entity that handles the shipment keeps records of its own actions—such as dispatch, custody transfers, and delivery. The goal is to create a clear chain of custody so investigators can trace a product’s journey and pinpoint where a problem occurred without requiring every company to duplicate all records for every shipment.

This approach keeps recordkeeping focused and manageable: it avoids the burden of a single universal record and prevents gaps that would occur if no records were kept or if records were kept for shipments in which a party had no involvement. Practical example: the shipper maintains documents about the product, the carrier maintains transit records, and the consignee records receipt. Taken together, these records provide complete traceability while reflecting each party’s actual role.