Import Alert 52-12
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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 # 52-12
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Infant Pewterware Cups"
Reason for Alert:
In September 1992, as part of CFSAN Field Assignment #92-30, DAL-DO collected a domestic import (DI) sample of 12 units of antique finish pewterware infant cups from 22 cups in stock at the dealer firm in Houston, Texas.
Analyses of 6 cups disclosed lead levels at above 0.5 ppm. On November 18, 1992, a follow up DI sample of 12 shiny finish pewterware cups from the same manufacturer was collected from 48 cups at the same dealer. Analyses of 6 cups revealed lead levels at 0.8 ppm and 0.9 ppm in all 6 units analyzed.
In addition, BUF-DO detained a shipment of pewter baby cups on July 25, 1994, that were found to contain leachable levels of lead ranging from 1.5 to 6.4 ppm.
Analyses of 6 cups disclosed lead levels at above 0.5 ppm. On November 18, 1992, a follow up DI sample of 12 shiny finish pewterware cups from the same manufacturer was collected from 48 cups at the same dealer. Analyses of 6 cups revealed lead levels at 0.8 ppm and 0.9 ppm in all 6 units analyzed.
In addition, BUF-DO detained a shipment of pewter baby cups on July 25, 1994, that were found to contain leachable levels of lead ranging from 1.5 to 6.4 ppm.
Guidance:
Districts may detain, without physical examination, all pewterware cups from firms identified in the attachment for this alert.
Product Description:
Infant Pewterware Cups (Shiny and Antique Finishes)
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain lead, a food additive which is unsafe within the meaning of Section 409 [Adulteration, Section 402(a)(2)(C).]"
OASIS charge code - UNSAFE ADD
OASIS charge code - UNSAFE ADD
IRELAND
Emerald Freight Express
Date Published : 09/18/2009
Santryhall Industrial Estate , Santry , Dublin, IRELAND
52 A Y - 04 Pewterware (Kitchen and Tableware, Cups, Mugs, Plates, Platters, Bowls, Etc.)
Date Published: 09/18/2009
Desc:infant pewter cups shiny and antique finishes
Problems:
LEAD;
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