CSMS# 11-000273 - FDA Review of Private Laboratory Analyses for Papayas
U.S. Customs and Border Protection sent this bulletin at 10/28/2011 05:45 PM EDTYou are subscribed to Automated Broker Interface for U.S. Customs and Border Protection. This information has recently been updated, and is now available.
10/28/2011 06:38 PM EDT
Automated Broker Interface
Date: October 28, 2011
Subject: FDA Review of Private Laboratory Analyses for Papayas
On August 25, 2011, FDA issued Import Alert #21-17, "Countrywide Detention Without Physical Examination of Papaya from Mexico."
As indicated in Import Alert #21-17, FDA believes detention without physical examination (DWPE) of all fresh papayas from Mexico is appropriate based on the presence of salmonella. In order to obtain an FDA release for an entry of papayas from Mexico, the importer has to demonstrate that each entry is free from salmonella. In most instances, a laboratory analysis conducted by a third-party laboratory will be sufficient to justify release of the entry.
However, FDA review of third-party analytical packages has revealed numerous issues related to the analyses conducted and the information provided. Such issues could render the analytical package unacceptable, which would result in a refusal of admission for the entry. Rather than taking this step, FDA's laboratory and compliance personnel have been working with the third-party laboratories to reconcile these issues so that the analytical package adequately documents that the product does not contain salmonella.
In addition to working with the third-party laboratories on individual submissions, FDA is also trying to get the third-party laboratories to a point where FDA has sufficient confidence the third-party laboratories can consistently submit acceptable analytical packages. Once a particular third-party laboratory has achieved this, their analytical packages will not require such a stringent review and the entry process may be expedited for some shipments.
This collaboration between FDA laboratory personnel and third-party laboratories takes time and is a reason for perceived delays in the review process. FDA will not issue releases based upon third-party laboratory analyses that are not acceptable. Importers may continue to expect delays in FDA releases of papayas from Mexico until their third-party laboratory can demonstrate an ability to consistently submit acceptable analytical packages.
Unfortunately, FDA does not recommend specific private laboratories. FDA is encouraging importers to verify a private laboratory�s capabilities, quality controls, and successful submission history of Salmonella analysis for papaya with the Agency. FDA is working as expeditiously as possible to get the third-party laboratories to correct their problems so that the third-party laboratories will submit acceptable analytical packages; however, the responsibility ultimately rests with the importer to use sound judgment in the selection of a third-party laboratory and the third-party laboratories to submit acceptable analytical packages.
Date: October 28, 2011
Subject: FDA Review of Private Laboratory Analyses for Papayas
On August 25, 2011, FDA issued Import Alert #21-17, "Countrywide Detention Without Physical Examination of Papaya from Mexico."
As indicated in Import Alert #21-17, FDA believes detention without physical examination (DWPE) of all fresh papayas from Mexico is appropriate based on the presence of salmonella. In order to obtain an FDA release for an entry of papayas from Mexico, the importer has to demonstrate that each entry is free from salmonella. In most instances, a laboratory analysis conducted by a third-party laboratory will be sufficient to justify release of the entry.
However, FDA review of third-party analytical packages has revealed numerous issues related to the analyses conducted and the information provided. Such issues could render the analytical package unacceptable, which would result in a refusal of admission for the entry. Rather than taking this step, FDA's laboratory and compliance personnel have been working with the third-party laboratories to reconcile these issues so that the analytical package adequately documents that the product does not contain salmonella.
In addition to working with the third-party laboratories on individual submissions, FDA is also trying to get the third-party laboratories to a point where FDA has sufficient confidence the third-party laboratories can consistently submit acceptable analytical packages. Once a particular third-party laboratory has achieved this, their analytical packages will not require such a stringent review and the entry process may be expedited for some shipments.
This collaboration between FDA laboratory personnel and third-party laboratories takes time and is a reason for perceived delays in the review process. FDA will not issue releases based upon third-party laboratory analyses that are not acceptable. Importers may continue to expect delays in FDA releases of papayas from Mexico until their third-party laboratory can demonstrate an ability to consistently submit acceptable analytical packages.
Unfortunately, FDA does not recommend specific private laboratories. FDA is encouraging importers to verify a private laboratory�s capabilities, quality controls, and successful submission history of Salmonella analysis for papaya with the Agency. FDA is working as expeditiously as possible to get the third-party laboratories to correct their problems so that the third-party laboratories will submit acceptable analytical packages; however, the responsibility ultimately rests with the importer to use sound judgment in the selection of a third-party laboratory and the third-party laboratories to submit acceptable analytical packages.
Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.
This service is provided to you at no charge by U.S. Customs and Border Protection.
Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes.
 |
 |