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IA #16-100, REVISED 6/4/96 - ATTACHMENT REVISED 8/12/94

SUBJECT:    ***Detention Without Physical Examination of Langostinos Due to
            the Presence of Staphylococcus Aureus and E. Coli/ Coliforms***

            NOTE:  This alert is being revised to provide changes to format/
            terminology and are bracketed by asterisks (***).

            ***Note:  This import alert contains guidance to FDA field
            personnel only.  It does not establish any requirements, or create
            any rights or obligations on FDA or on regulated entities.***

TYPE OF ALERT:    ***Detention Without Physical Examination***

PRODUCT      :    Frozen Langostinos

PRODUCT CODE :    16J--05

PROBLEM      :    Staphylococcus Aureus (FLST)
                  E. coli/coliforms (FLEC)

PAC FOR
COLLECTION   :    03844

COUNTRY      :    See Attachment

MANUFACTURER/
SHIPPER      :    See Attachment

MANUFACTURER/
SHIPPER I.D.#:    See Attachment

IMPORTER'S
I.D. #       :    N/A

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)]."

RECOMMENDING
OFFICE       :    Import Branch, ***New England District***, HFR-NE150

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 Attachment to
                  this alert have met the criteria for ***detention without
                  physical examination***.

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

GUIDANCE     :    ***Districts may detain, without physical examination*** all
                  frozen langostinos from the firms listed on the attachment.
                  Surveillance for presence of microbiological contamination
                  of langostinos from other firms appears warranted.

PRIORITIZATION
GUIDANCE     :    I

FOI          :    No purging is required

KEYWORDS     :    Langostinos, Lobsters, Staphylococcus aureus, E. coli,
                  coliform, bacteria

PREPARED BY  :    Linda A. Wisniowski, DIOP, 301-443-6553.

               Attachment - Import Alert #16-100 Revised 8/12/94


              FIRMS UNDER DETENTION WITHOUT PHYSICAL EXAMINATION


                                CHILE (CL 275)


FIRM NAME & ADDRESS                             AUTOMATIC DETENTION DATE


Pesquera Santa Lucia S.A.                       8/16/93
Camina Publico Quintero S/M
Casiffa 131 Quintero, Chile
MID #CLPESSANQUI