IA #29-02, 3/27/07 - IMPORT ALERT #29-02, "DETENTION WITHOUT PHYSICAL EXAMINATION OF BOTTLED WATER DUE TO ARSE
NIC", ATTACHMENT 4/6/07
This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s
) and/or product(s) at issue. It does not create or confer any rights for, or on any person, and does not ope
rate to bind the FDA or the public.
TYPE OF ALERT: Detention Without Physical Examination
PRODUCT: Bottled Water
PRODUCT 29W[][]01
CODE: 29W[][]02
PROBLEM: Contains arsenic
PAF: MET
PAC: 04019A
OASIS CHARGE
CODE: POISONOUS
COUNTRY: See Attachment
MANUFACTURER/: See Attachment
SHIPPER
CHARGE: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appea
rs to contain a poisonous and deleterious substance (i.e., arsenic) which may render it injurious to health. [
Adulterated 402(a)(1)]."
RECOMMENDING
OFFICE: LOS-DO (HFR-PA256)
REASON FOR
ALERT: Los Angeles District was among several Districts that sampled products under the FY 07 sample
schedule for Compliance Program 7304.019AC, Toxic Elements in Foods and Radionuclides in Foods (Domestic and I
mport).
Three samples of bottled water imported from three different manufacturers in Armenia
were found to contain high levels of arsenic. Arsenic is a toxic substance and known human carcinogen that ca
n occur in water sources throughout the world. Symptoms of acute arsenic exposure usually occur within severa
l hours of consumption. The most likely effects include nausea, vomiting, diarrhea, and stomach pain. Over t
he period of a few days to weeks, the kidneys, liver, skin, and cardiovascular and nervous systems could be af
fected. Extended exposure could lead to cancer and death.
FDA testing of this water revealed greater than 450 micrograms of arsenic per liter.
FDA's standard of quality for bottled water allows no more than 10 micrograms per liter.
GUIDANCE: Districts may detain without physical examination all bottled water manufactured by fi
rms identified on the attachment to this alert.
FOI: No Purging Required
PREPARED BY: Judy Baron, DIOP, HFC-170
DATE LOADED
INTO FIARS: March 27, 2007
ATTACHMENT TO IMPORT ALERT #29-02, 4/6/07
FIRM NAME & ADDRESS
Arpi Mineral Water Plant JSC
Alaverdian 83
Vaik, Armenia
FEI# 3004328027
Jermuk CJSC
aka Jermuk Mayr Gortsaran CJSC
1 Gortaranain Str.
(Gortsaranajin 1)
Jermuk, Armenia
FEI# 3004287962
Jermuk Group CJSC
1, Barekamutian, Str.
Jermuk, Armenia
FEI# 3004141192
Sam Har LLC 4/6/07
2 Karmir Banakayinneri Str
Abovian, Armenia 378510
FEI# 3005344241
Sam Har LTD 4/6/07
2 Shinararner Str
Abovian, Armenia 378510
FEI# 3005159482
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