FDAImports.com Convinces an Obstinate FDA to Remove Client from Import Alert #72-03 Red List
Tags: "Benjamin England", 72-03, agency, arguments, attorney, attorneys, clients, compliance, contamination, detention, ears, examination, FDA, import alert, inspections, mexico, pet treats, pig, processing, rawhide, red list, salmonella, sampling, source, testing, treatment
The www.FDAImports.com, LLC expert team of FDA consultants and FDA attorneys obtained removal of another client processor from another FDA Import Alert, this time, Import Alert #72-03, “Detention without Physical Examination and Intensified Coverage of Pig Ears and other Pet Treats Due to the Presence of Salmonella.”
A 2004 FDA examination and sampling found Salmonella in untreated rawhide scraps. FDA placed the Mexican processor on the Import Alert Red List. That shipment was a one-time event, as the Mexican supplier was in the business of processing and shipping finished rawhide pet chews and treats – not unfinished rawhide scraps. However, in 2010, FDA started to extend the practical effect of the import alert to the processor’s finished pet chews and treats, resulting in increased import examinations, automatic detentions, delays and costs on shipments that were not even subject to the import alert listing.
Ordinarily, under unpublished FDA policies and procedures, the agency expects an import alert petitioner to identify the source of the contamination and document the processing changes implemented by the firm to ensure future shipments will not be similarly contaminated. In this case, the original shipment of unprocessed rawhide scraps was sourced from a third party and was not processed; thus there were no processing records to look to and not processing changes to make to correct a problem that did not originate with the listed firm. Although it took some arguing with FDA, FDAImports.com eventually convinced FDA that the unpublished policies and procedures were inapplicable and FDA would have to rely on the current processing and heat treatment, along with sampling and testing evidence to prove no future shipments of any rawhide (scraps or processed) would be contaminated.
FDAImports.com, LLC worked vigorously to remove the company from continuing on the Red List of Import Alert #72-03. This is exemplary encounter with the FDA and Import Alert petitions reflect our consultants’ and attorneys’ dedication to ensuring our clients succeed. When the FDA can so carelessly apply an Import Alert listing for one unprocessed, raw product to another processed and finished product, it can justifiably raise anxiety for all manufacturers and importers of safe products.
Import Alert petitions are not an “easy-win” and all cases turn on the specific facts, but FDAImports.com is dedicated to our clients’ successes and will use all available evidence and arguments to obtain best results.
- Benjamin L. England, Founder