Next Upcoming Seminar: Dairy Processing 101 Seminar – June 13-15, 2017

Specializing in FDA Regulatory Matters

Warning Letters, 483s and Other Responses Required by FDA

FDA regularly monitors companies for compliance with any number of manufacturing, labeling and claims and other regulatory requirements. Should your company receive such a letter, with response back to FDA required, EAS can assist with the preparations of responses as well as remediation plans to bring your company’s issues back into FDA compliance.

While FDA generally provides a short notice window in the event of either a facility or paper audit, the time to prepare for such an event is generally too limited to provide sufficient understanding and correction of deficiencies. EAS can hold a “mock-inspection” looking for the same materials and requirements as FDA, as well as an improvement plan to help your company’s GMPs stay in good order.