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| TO: | All Regional Food and Drug Directors Attn: Regional Milk Specialists |
| FROM: | Milk Safety Branch (HFS-626) |
| SUBJECT: | Updated Official Laboratory Evaluation Forms (FDA-2400 Series) |
Sixteen (16) Official Laboratory Evaluation Forms (FDA-2400 Series) utilized in the evaluation of milk labs, certified industry supervisor (CIS) facilities or screening facilities as required by the National Conference on Interstate Milk Shipments (NCIMS) Program have been updated and are attached in PDF format (2400, 2400a, 2400b-1, 2400b-3, 2400d, 2400h, 2400h-1, 2400h-2, 2400h-3, 2400h-4, 2400j-1, 2400j-2, 2400m, 2400n [App. N Gen Requirements], 2400n-x [Charm SL/SL-6] and 2400n-x [Idexx New Snap]).
All required evaluations cited above shall be conducted using these most recently updated and approved FDA-2400 Series evaluation forms. Federal or state laboratory evaluation officers (LEOs) shall determine if the laboratory, equipment, records and techniques of analysts are in compliance with these FDA-2400 Series evaluation forms beginning 6 months from the issue date of this memorandum, December 1, 2005, with the exception of 2400 (Cultural Procedures), 2400n-x [Charm SL/SL-6] and 2400n-x [Idexx New Snap] which remain in effect due to lack of substantive changes.
An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web site at http://www.cfsan.fda.gov at a later date.
If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to or .
/ss/
Larry Maturin, PhD, Chief
CAPT Robert F. Hennes, RS, MPH, Chief
Laboratory Quality Assurance Team
Milk Safety Team
Attachments:
