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Import Alert 21-06

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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 # 21-06
Published Date: 10/11/2011
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination and Intensified Coverage of Canned Peaches From Greece for Pit Fragments and Mold"

Reason for Alert:
Between December 15, 1994 and January 30, 1995, 10 of 10 shipments of canned peaches from Union of Agricultural Coop, Giannitsa, Greece, were sampled by Orlando (currently Florida) district, found violative, and detained and refused entry (9 because of mold and pit fragments, 1 because of insect filth).

Between September 9, 1994 and January 24, 1995, 4 of 5 shipments of canned peaches from Prodromos Pavlides, S.A., Thessaloniki, Greece were sampled by Orlando (currently Florida) district, found violative for pits/pit fragments, and detained and refused entry. In addition, New Orleans (currently Nashville) district sampled an entry of canned peaches from Prodromos Pavlides, S.A., which was found violative for pits, and was detained on December 16, 1994.

Also, Orlando (currently Florida) district found canned peaches from two other firms in Greece, Almac, S.A. and Confruta S.A. Canning Ind. violative for mold and pits/pit fragments.

Guidance:
Districts may detain without physical examination shipments of canned peaches from the firms identified on the Red List below for excessive pit fragments and mold.

*** Intensified coverage of the firms on the Yellow List may be warranted since product has been found violative for pits and/or mold. ***

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:
Canned peaches

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, in that it appears to contain mold [Adulteration, Section 402(a)(3)]."

OASIS charge code - FILTHY

AND

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it purports to be canned yellow peach slices, a food for which a standard of quality has been prescribed by regulation (21 CFR 145.170(b)), promulgated pursuant to Section 401, and its quality appears to fall below such standard due to excessive pits and pieces of pits (Section 145.170(b)(1) (viii)), and its label fails to bear, in such manner and form as regulations specify, a statement that it falls below such standard [Misbranded 403(h)(1)]."

OASIS charge code - STD QUALIT

Countries

GREECE
Red - Firms, countries and/or products that are subject to detention without physical examination of the product identified in the criteria of the alert
Yellow - List of firms and their products subject to intensified surveillance; or firms that may have satisfied GMP issues of concern, but the nature of violations may warrant further field examinations of individual entries and/or additional analyses (a.k.a. Yellow List)
Green - Firms are excluded from the criteria of the alert
Go to Red List   Yellow List  

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)



GREECE

Agricultural Products S.A.
Date Published : 09/16/2009

Unknown , Skydra, GREECE
21 G - E 13 Peach (Pit Fruit)
Date Published: 09/16/2009


Union Of Agricultural
Date Published : 09/16/2009

9 Papadopoulou Str , Giannitsa, GREECE
21 G - E 13 Peach (Pit Fruit)
Date Published: 09/16/2009



List of firms and their products subject to intensified surveillance; or firms that may have satisfied GMP issues of concern, but the nature of violations may warrant further field examinations of individual entries and/or additional analyses (a.k.a. Yellow List)



GREECE

Almac S A
Date Published : 09/16/2009

3 Premetis , Amarousio, GREECE
21 G - E 13 Peach (Pit Fruit)
Date Published: 09/16/2009


Confruta Sa
Date Published : 09/16/2009

2 N Kountouriotti St , Thessaloniki, GREECE
21 G - E 13 Peach (Pit Fruit)
Date Published: 09/16/2009


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