Import Alert 15-01

(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 # 15-01
Published Date: 03/21/2018
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Preserved Duck Eggs Due to Lead"

Reason for Alert:

SAN-DO analysis of a sample of preserved duck eggs from Taiwan (sample
#1905971, Grand Western Foods) found lead levels ranging from 510 ppb to 640 ppb. SAN-DO analysis of a sample of preserved duck eggs from Hong Kong (sample #3037128, S.B. Trading Co. Ltd.), found lead levels ranging from 1400 ppb to 1900 ppb.

Guidance:

Districts may detain, without physical examination, preserved duck eggs from the firms listed in the Red List to this alert.

Contact the Division of Field Science at 301 796-6600 for questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:

Preserved Duck Eggs

Charge:

“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. [Adulteration, Section 402(a)(1)]” Contains:

OASIS charge code - POISONOUS

and "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain excessive lead residues, an unsafe food additive within the meaning of Section 409. [Adulteration, Section 402(a)(2)(C)]"

OASIS charge code - UNSAFE ADD

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


CHINA


Jiangsu Maochun Food Co., Ltd.
Date Published : 03/24/2011
88 Ningyan Rd, North Longwangmiao Bridge , Shengao Town , Jiangyan City,, Jiangsu Province CHINA
15 A - - 03 Eggs, Duck, In Shell
Date Published: 03/24/2011

Desc: Preserved Duck Eggs


HONG KONG


S. B. Trading Co Ltd
Date Published : 09/10/2009
21/Fl, Flat B, Cheung Lee Ind Bldg , 9 Cheung Lee Street, Chai Wan , Hong Kong, HK-NA HONG KONG
15 A - - 03 Eggs, Duck, In Shell
Date Published: 09/10/2009

Problems: LEAD;


TAIWAN


Grand Western Foods Corp.
Date Published : 09/10/2009
No. 303 Chung Ming South Road , 20th Flr, #152, Sec. 1 , Taichung, TAIWAN
15 A - - 03 Eggs, Duck, In Shell
Date Published: 09/10/2009

Notes: Preserved Duck Eggs
Problems: LEAD;

Tainan County Duck Breeding Corporation
Date Published : 09/10/2009
10 Tar-ming Li , Hsueh-Chia Town, Tainan County TAIWAN
15 A - - 03 Eggs, Duck, In Shell
Date Published: 09/10/2009

Notes: Preserved Duck Eggs
Problems: LEAD;