| Title: | OGA-FDA Revisions to Melamine-related Import Alerts 72-05, 99-29, 99-30, and 99-31 |
|---|---|
| Date: | 2009-03-02 |
| To: | abi |
| Links: | previous, next |
Title: OGA-FDA Revisions to Melamine-related Import Alerts 72-05, 99-29, 99-30, and 99-31
Date: 3/2/2009
To: All ABI Filers
On 2/23/2009, FDA revised the four melamine-related Import Alerts (72-05, 99-29, 99-30, 99-31). Of particular note is a change to three of the alerts (72-05, 99-29, and 99-31) indicating a web link used to find appropriate methods. This change brings consistency throughout all the alerts as to what is expected from private laboratory analyses.
Although these revisions were issued and took effect 2/23/2009, FDA will not apply the revision to any entry offered for entry 3/4/2009 or before.
Private laboratory submissions of entries with a date of entry of 3/5/2009 or later will be expected to meet the method performance of the LC-MS/MS methods available at http://www.cfsan.fda.gov/~comm/labmeth.html#melamine
Importers utilizing private laboratory analyses in an attempt to secure release of an shipment detained pursuant to any of the mentioned import alerts should ensure their laboratory is performing an acceptable analysis.
The alerts can be found at the following link: http://www.fda.gov/ora/fiars/ora_import_alert_list.html
The link for appropriate analytical methods: http://www.cfsan.fda.gov/~comm/labmeth.html#melamine
Contact FDA's Division of Import Operations and Policy at (301) 443-6553 with any questions about this message.