Import Alert 24-21
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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 # 24-21
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examintion of Parsley and Cilantro from Agricola Herendira, Mexico Due to Shigella Sonnei"
Reason for Alert:
In August 1998, there were numerous outbreaks of Shigella sonnei in the United States and Canada. In many of the reported cases, subsequent traceback investigations and epidemiological data implicated fresh parsley from Agricola Herendira S. de R.L. de C.V., Mexico as the cause of the outbreaks.
On September 9 and 10, 1998, FDA received reports of an additional outbreak of Shigella sonnei. Subsequent traceback investigation and epidemiological data implicated fresh cilantro from Agricola Herendira, Mexico as the cause of the outbreak.
Due to the non-uniform nature of contaminant such as Shigella sonnei in foods of this type, any submission of private laboratory testing results indicating a non-violative product should be discussed with CFSAN, Office of Field Programs Import Branch, before they are determined to be sufficient to remove the appearance of the violation.
On September 9 and 10, 1998, FDA received reports of an additional outbreak of Shigella sonnei. Subsequent traceback investigation and epidemiological data implicated fresh cilantro from Agricola Herendira, Mexico as the cause of the outbreak.
Due to the non-uniform nature of contaminant such as Shigella sonnei in foods of this type, any submission of private laboratory testing results indicating a non-violative product should be discussed with CFSAN, Office of Field Programs Import Branch, before they are determined to be sufficient to remove the appearance of the violation.
Guidance:
Districts may detain fresh parsley and fresh cilantro from Agricola Herendira, Mexico without physical examination.
Product Description:
Fresh Parsley and Fresh Cilantro
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to bear or contain a poisonous or deleterious substance which may render it injurious to health [adulteration, 402(a)1]."
OASIS charge code - POISONOUS
OASIS charge code - POISONOUS
MEXICO
Agricola Herendira,S. De R.L. De C.V.
Date Published : 09/16/2009
San Marcos No. 198 Fracc Buenaventura , Ensenada, Baja CFA, MEXICO
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