Import Alert 16-100
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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 # 16-100
Published Date: 10/07/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Langostinos Due to the Presence of Staphylococcus Aureus and E. Coli/Coliforms"
Reason for Alert:
Problems involving Staphylococcus aureus and E. coli/coliforms continue to be found by FDA in samples of langostinos from Chile. Firms listed in the Red List for this alert have met the criteria for detention without physical examination.
Guidance:
Districts may detain, without physical examination, all frozen langostinos from the firms listed on the Red List for this alert.
Surveillance for presence of microbiological contamination of langostinos from other firms appears warranted.
Methodology: Staph aureus - BAM, 7th Edition 1992, Chapter 12, Most Probable Number (MPN) method A-D * E;
E. coli/coliforms - BAM, 7th Edition 192, Chapter 4 - C, D, F1;
Aerobic Plate Count (APC) - BAM, 7th Edition 1992, Chapter 3- A, B C1, D.
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.
Surveillance for presence of microbiological contamination of langostinos from other firms appears warranted.
Methodology: Staph aureus - BAM, 7th Edition 1992, Chapter 12, Most Probable Number (MPN) method A-D * E;
E. coli/coliforms - BAM, 7th Edition 192, Chapter 4 - C, D, F1;
Aerobic Plate Count (APC) - BAM, 7th Edition 1992, Chapter 3- A, B C1, D.
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:
Frozen Langostinos
Charge:
For Staphylococcus aureus and/or E. coli/coliforms, charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of a filthy, putrid, or decomposed substance, by reason of presence therein of Staphylococcus aureus and/or E. coli/coliforms, or to be otherwise unfit for food. [Adulteration, Section 402(a)(3)]"
OASIS charge code - FILTHY
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of a filthy, putrid, or decomposed substance, by reason of presence therein of Staphylococcus aureus and/or E. coli/coliforms, or to be otherwise unfit for food. [Adulteration, Section 402(a)(3)]"
OASIS charge code - FILTHY
CHILE
Pesquera Santa Lucia S.A.
Date Published : 09/10/2009
Casilla 131 , Quintaro, CHILE
16 J - - 07 Langostino, lingostino
Date Published: 09/10/2009
Notes:bacteria
Problems:
STAPHYLOCOCCUS : AUREUS;
ESCHERICHIA : COLI (TYPICAL);
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