Congressional Representatives Press FDA For Action on Third-Party AuditsJanuary 23, 2012
By Ricardo Carvajal –
In tandem with the release of a House Energy and Commerce Committee staff report on last year’s outbreak of Listeria monocytogenes in cantaloupe, members of that committee sent Commissioner Hamburg a letter calling for reforms in the conduct and oversight of third-party audits. Based on the findings of the Committee report, the letter calls for FDA to develop regulations and guidance to address the following issues noted with the third party audit of Jensen Farms (the producer of the cantaloupe implicated in the outbreak):
- The audit was geared only toward assessing compliance with FDA regulations, and not FDA guidance or best industry practices.
- Jensen Farms was not required to correct any deficiencies noted in the audit.
- The auditing firm does not report findings to federal, state, or local officials, even when there is an egregious deficiency that prompts immediate termination of the audit and results in failure of the audit.
- Jensen Farms had ample advance notice of the audit, and the audit was relatively brief.
- Jensen Farms had final say over the selection of auditors, thereby giving rise to a potential conflict of interest. In addition, the auditing firm had recommended processing equipment that was faulted in FDA’s subsequent investigation.
The letter asserts that these issues are similar to those identified in prior committee investigations of outbreaks of Salmonella in which third party audits were faulted.
As we noted in a recent posting, FDA’s oversight of food facility inspections conducted by state agencies has already come under scrutiny by the HHS Office of Inspector General. Thus, food companies can expect the reliability of non-FDA inspections and audits to remain a hot topic – one doubtless fueled by the naming of third-party auditors in follow-on litigation.