Wellington Foods was audited by the USFDA in May 2013 for 21 CFR Part 111 compliance. Wellington’s Quality Systems and Regulatory Compliance Department headed the audit team and with a representative from executive management spent the entire audit with the FDA, hosting facility tours, providing requested quality documents, MMR’s, test results, SOP’s, training documentation, material receiving qualifications etc. The audit was very thorough, focusing specifically on DS regulatory requirements and drilling down to specific levels of detail across many categories.
The audit was concluded with a finding of no objectionable conditions, no citations (483’s) and no outstanding issues.
The entire team at Wellington Foods is aware that quality and regulatory compliance is a goal to which there is no finish line. It is a process of ongoing improvement which requires discipline, organization and attention to detail. We are encouraged by our recent performance in the FDA audit, and will continue to strive to meet regulatory requirements and our customer’s high expectations.