IA #31-03 REVISION - 8/23/01, IMPORT ALERT #31-03, 8/8/01, "***DETENTION
WITHOUT PHYSICAL EXAMINATION*** OF GUANABAN***A*** (SOURSOP)
Attachment 11/20/07
NOTE: This revision is being issued to revise the alert into the current
format and terminology. Changes are bracketed by asterisks (***).
TYPE OF
ALERT: *** Detention Without Physical Examination (DWPE)***
PRODUCT: Guanabana (Soursop) drinks, juices, nectars, etc.
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.
PRODUCT
CODE: 20S[][]99
PROBLEM: Toxic material from the fruit seeds was incorporated into the
finished product during the manufacturing process
PAF: *** BIO ***
PAC: 07F800
COUNTRY: See Attachment
MANUFACTURER/
SHIPPER
ID #: See Attachment
IMPORTER'S
I.D.#: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain a poisonous and
deleterious substance which may render it injurious to health
[Adulteration, Section 402(a)(1)]."
OASIS CHARGE
CODE: ***POISONOUS***
RECOMMENDING
OFFICE: Division of Import Operations and Policy, HFC-170
REASON FOR
ALERT: In February 1990, thirty-four adults and children drank "Rain
Drop" Guanabana Drink from Mexico and within 15 minutes they began
vomiting. Dallas district laboratory performed microscpic
examination of the product and found some seed cells in all
"suspect" codes examined. The literature ***indicates*** the
seeds are toxic and an oil expressed from the seeds has been used
as an insecticide and fish poison. According to the Mexican
authorities, the product is only manufactured for exportation and
not consumed in Mexico.
***In*** February 1993, a sample of Iberia brand soursop nectar
(guanabana) from the Dominican Republic was recalled (already on
domestic status) due to the presence of the toxic guanabana seeds.
***GUIDANCE:*** ***Districts may detain without physical examination*** all
shipments of guanabana (soursop) drinks, juices, nectars,
etc. from manufacturers/shippers in the attachment.
Increase surveillance of this product from other countries.
Samples collected for analysis should be forwarded to the
following laboratories:
Northeast, Mid-Atlantic and Southwest regions to Southeast
Regional Laboratory
Midwest and Southwest regions to Dallas, Pacific Region to Los
Angeles Laboratory
***For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301) 827-
7605.***
***PRIORITIZATION
GUIDANCE: I***
FOI: No purging is necessary.
KEYWORDS: Guanabana, Soursop, Drink, Nectar, Juice, Guyabano
PREPARED
BY: Jack Geltman, DIOP, 301-443-6553
DATE LOADED
INTO FIARS: August 23, 2001 Attachment to Import Alert #31-03 11/20/07
LIST OF MANUFACTURERS/SHIPPERS ON ***DETENTION WITHOUT PHYSICAL EXAMINATION***
DOMINICAN REPUBLIC (DO, 320)
Caribex Dominicana SA
Apartado 409-2
Santo Domingo, Dominican Republic
MID #DOCARDOM409SAN
Goya Santo Domingo SA Guanabana fruit beverage
Km. 17 Ave. 6 De Noviembre 20S[][]99
San Cristobal, Dominican Republic 11/20/2007
FEI# 3004313116
MEXICO (MX, 595)
Jugos del Valles S.A. de C.V.
Km 43.5 Auto Pisto Mexico
Tepot Zotlan Tado de Mexico 54600
MID #MXJUGDEL435TEP
PHILIPPINES (PH, 725)
Summer Fruit Inc. (Mfr)
Marsman-Drysdale Group
Marsman Bldg.
Sen. Gil. J. Puyat Avenue
Cor. Washington Street
Makati, Metro Manila
MID #PHSUMFRUMET
Km 42 By Pass, Bgy, San Vicente (Factory)
Silang, Cavite, Philippines
MID #PHSUMFRU42CAV
***Profood International Corp. Aseptic Guyabana (sic) Puree
653 Hiway Maguikay, No. 7 /20U[][]99
Gochan Compound
Mandaue City, Philippines 6000
FEI #8192***
VIETNAM (VN)
Agrimexco Fzn. Soursop Paste/
176 Nai Ba Trung St. 22H[][]04
District 1 4/23/01
Ho Chi Minh City, Vietnam
FEI #1000429310
Lucky Shing Enterprise Co. Ltd. Frozen Soursop Paste/
579 Quoc Lo An Lac Village 22H[][]04/22I[][]04
Ho Chi Minh City, Vietnam 4/11/01
FEI #3001757812
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