Import Alert 37-04
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 37-04
Published Date: 10/11/2011
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination of Mole Paste and Mexican-Styled Hot Sauce Due to Filth"
Reason for Alert:
Since 1982 numerous entries of Mole Paste and other types of Mexican styled hot sauces continue to be detained due to filth contamination. It is believed that a major ingredient, dried peppers, are handled in an undesirable manner that results in contamination by insects, rodents, birds and other sources of filth.
Surveillance of one major producer revealed repeated violations; a consultation was arranged between the firm and Dallas District. Despite an agreement on a course of action, DAL-DO did not receive confirmation that these improvements were initiated.
Subsequent testing of seven different lots of Mole Paste (Dona Maria brand) revealed that six of the lots contained violative levels of rodent hairs, cat and dog hairs, insect filth and mites. CFSAN concurs with the detention of this product based on the reported filth findings.
Shipments found violative in the past include products labeled as hot sauce, chili sauce, mole sauce and brava sauce as well as mole paste.
Surveillance of one major producer revealed repeated violations; a consultation was arranged between the firm and Dallas District. Despite an agreement on a course of action, DAL-DO did not receive confirmation that these improvements were initiated.
Subsequent testing of seven different lots of Mole Paste (Dona Maria brand) revealed that six of the lots contained violative levels of rodent hairs, cat and dog hairs, insect filth and mites. CFSAN concurs with the detention of this product based on the reported filth findings.
Shipments found violative in the past include products labeled as hot sauce, chili sauce, mole sauce and brava sauce as well as mole paste.
Guidance:
Districts may detain, without physical examination, all shipments of the product identified from the manufacturer/packer/shipper listed in the attachment for this alert.
Increased surveillance of similar products from other manufacturers is indicated as program time allows.
Method used by the Dallas Laboratory:
1) Basic pretreatment as per LIB #2866 followed by
2) Final extraction using AOAC 978.20 (60/20 Ethanol/Water) or AOAC 975.49(b) (40/10 Isopropyl Alcohol/Water)
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Increased surveillance of similar products from other manufacturers is indicated as program time allows.
Method used by the Dallas Laboratory:
1) Basic pretreatment as per LIB #2866 followed by
2) Final extraction using AOAC 978.20 (60/20 Ethanol/Water) or AOAC 975.49(b) (40/10 Isopropyl Alcohol/Water)
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Mole Paste and Mexican Hot Sauces
Charge:
"The article appears to consist in whole or in part of a filthy, putrid or decomposed substance or is otherwise unfit for food." [Adulteration, Section 402(a)(3)]"
OASIS charge code - FILTHY
OASIS charge code - FILTHY
Countries
MEXICO
(37 J - - 18) Mole Sauce
(37 K - - 18) Mole Paste
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