Import Alert 25-19
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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 # 25-19
Published Date: 03/18/2011
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination of Fresh Garlic and Garlic Products Due to Mold"
Reason for Alert:
In the last six months, LOS-DO has reported an increase in the number of detentions and refusals of fresh garlic from the Peoples Republic of China (PRC) due to mold/decomposition and/or insect filth/damage. Of 13 shipments of fresh garlic entered from 09/01/93 to 03/07/94 that have been sampled and analyzed, 10 shipments (77% detention rate) have been detained with the percentage of rejects due to old/decomposition/insect filth ranging from 24% to 61.1%. This detention rate represented 10 different PRC manufacturers/shippers.
During this same time period, New York district had detained 8 of 11 shipments (73% detention rate) of fresh garlic from 3 different PRC manufacturers/shippers. Percentages of rejects for old/ decomposition/insect damage ranged from 12% to 48%.
Seattle district reported detaining and refusing garlic products due to decomposition. These had been repacked and processed by Canadian firms using garlic products from PRC.
Orlando district (HFR-SE240) reported that shipments of fresh garlic from Argentina, represented by sample numbers 1898962 and 1898975, were found to contain decomposition, mold and insect filth and sample number 1898987, was found to contain mold and insect filth, which may have adverse consequences if consumed.
During this same time period, New York district had detained 8 of 11 shipments (73% detention rate) of fresh garlic from 3 different PRC manufacturers/shippers. Percentages of rejects for old/ decomposition/insect damage ranged from 12% to 48%.
Seattle district reported detaining and refusing garlic products due to decomposition. These had been repacked and processed by Canadian firms using garlic products from PRC.
Orlando district (HFR-SE240) reported that shipments of fresh garlic from Argentina, represented by sample numbers 1898962 and 1898975, were found to contain decomposition, mold and insect filth and sample number 1898987, was found to contain mold and insect filth, which may have adverse consequences if consumed.
Guidance:
Districts may detain, without physical examination, fresh garlic and garlic products from manufacturers/shippers listed in the attachment for this alert.
Continued surveillance of other firms shipping or processing garlic and garlic products is also warranted.
When districts encounter multiple violative shipments of fresh garlic from the same manufacturers/shippers, recommendation for detention without physical examination of Fresh Garlic and Garlic Products Due to Moldand accompanying information, including laboratory worksheets, should be forwarded to Division of Import Operations and Policy, HFC-170.
METHODOLOGY: Examine the fresh garlic and garlic products for mold, decomposition and insect filth in accordance to the instructions in the FDA Technical Bulletin Number 5 - Macroanalytical Procedures Manual, Chapter V, page V117-V118.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-5992.
Continued surveillance of other firms shipping or processing garlic and garlic products is also warranted.
When districts encounter multiple violative shipments of fresh garlic from the same manufacturers/shippers, recommendation for detention without physical examination of Fresh Garlic and Garlic Products Due to Moldand accompanying information, including laboratory worksheets, should be forwarded to Division of Import Operations and Policy, HFC-170.
METHODOLOGY: Examine the fresh garlic and garlic products for mold, decomposition and insect filth in accordance to the instructions in the FDA Technical Bulletin Number 5 - Macroanalytical Procedures Manual, Chapter V, page V117-V118.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-5992.
Product Description:
Fresh garlic and garlic products (See Attachment)
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 or to be otherwise unfit for food as it appears to contain mold, and/or insect filth, and/or appears to be decomposed [Adulteration, Section 402(a)(3)]."
OASIS charge code - FILTHY
OASIS charge code - FILTHY
ARGENTINA
Digta, S.A.
Date Published : 09/16/2009
Unknown , Mendoza, ARGENTINA
25 J - B 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:decomp; mold; insect filth
Digta, S.A.
Date Published : 09/16/2009
Unknown , Santa Fe, ARGENTINA
25 J - B 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:decomp; mold; insect filth
Digta, S.A.
Date Published : 09/16/2009
Unknown , Buenos Aries, ARGENTINA
25 J - B 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:decomp; mold; insect filth
CANADA
Pan Pacific Specialties Ltd
Date Published : 09/16/2009
1200 Raymur Ave , Vancouver, BC CANADA
25 J C - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:peeled garlic in 5 lb jar decomposition
Sun Pacific Food Processor
Date Published : 09/16/2009
1200 Raymur Avenue , Vancouver, BC CANADA
25 J C - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:peeled garlic in 5 lb jar decomposition
CHINA
Central China International Economic And Trading Corp
Date Published : 09/16/2009
22 Huangle Rd , Zhengzhou, CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 11/12/2010
Desc:white garlic bulb
Notes:decomp; mold; insect damage
Notes:decomp; mold; insect damage
China National Medicine & Health Products Import & Export Co
Date Published : 09/16/2009
Unknown , Qingdao, Shadong CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:white garlic bulb decomp; mold; insect damage
Henan Cereals Oils & Foodstuffs
Date Published : 09/16/2009
14 Jingqi Road , Zhengzhou, CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:white garlic bulb decomp; mold; insect damage
Shandong Medicines & Health Products Import /Export Corp.
Date Published : 09/16/2009
16 Baoding Road , Box 42 , Qingdao, CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:white garlic bulb decomp; mold; insect damage
Weifang Import & Export Corporation
Date Published : 09/16/2009
20 Qingnan Road , Weifang, CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 09/16/2009
Notes:white garlic bulb decomp; mold
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