Import Alert 16-23
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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 # 16-23
Published Date: 10/06/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Fresh and Fresh Frozen Lobster/Lobster Tails from India"
Reason for Alert:
From October 1, 1982, through March 31, 1983, FDA detained 14 of 32 entries of fresh/frozen lobster/lobster tails from India examined for decomposition (44% violation rate). Twelve of the detentions were solely for decomposition. Two were for both salmonella and decomposition.
FY 91 detention data shows five detentions representing five different firms in India. Review of sample collections and analyses data for FY 91 revealed that 13 had been collected with 4 violations for decomposition (31%). Also two of the four violative samples were from firms in the green list (Castlerock Seafoods and Sawant Food Poducts).
No detention data for Salmonella were noted although this should not be overlooked as a possible problem area.
FY 91 detention data shows five detentions representing five different firms in India. Review of sample collections and analyses data for FY 91 revealed that 13 had been collected with 4 violations for decomposition (31%). Also two of the four violative samples were from firms in the green list (Castlerock Seafoods and Sawant Food Poducts).
No detention data for Salmonella were noted although this should not be overlooked as a possible problem area.
Guidance:
Districts may detain, without physical examination, all fresh/frozen lobster tails from India, except those firms in the Green List. If a sufficient number of violative samples are noted for exempt firms, recommend to DIOP that these firms be removed from the Green List.
Audit of private laboratory results which are negative for decomposition is also recommended.
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.
Audit of private laboratory results which are negative for decomposition is also recommended.
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:
Fresh or Frozen Lobster/Lobster Tails
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 is otherwise unfit for food in that it appears to be decomposed [Adulteration, Section 402(a)(3)]."
OASIS charge code - FILTHY
OASIS charge code - FILTHY
Countries
INDIA
(16 J - - 04) Lobster
(16 J - - 06) Spiny Lobster, Rock Lobster
INDIA
Alsa Marine & Harvests
Date Published : 09/18/2009
10 Taylors Road , Kilpauk, TN INDIA
16 J - - 04 Lobster
Date Published: 09/18/2009
16 J - - 06 Spiny Lobster, Rock Lobster
Date Published: 01/20/2010
Amulya Seafoods
Date Published : 09/18/2009
166-A North Beach Road , C 96-97 Sipcot Industrial Complex , Tuticorin, Tamil Nadu INDIA
16 J - - 04 Lobster
Date Published: 09/18/2009
16 J - - 06 Spiny Lobster, Rock Lobster
Date Published: 01/20/2010
Castlerock Fisheries Pvt Ltd.
Date Published : 01/20/2010
M 33/34 - 1 Taloja Industrial Area , M.i.d.c. , Taloja, Maharashtra INDIA
16 J - - 04 Lobster
Date Published: 01/20/2010
16 J - - 06 Spiny Lobster, Rock Lobster
Date Published: 01/20/2010
Cham Ice and Cold Storage
Date Published : 01/20/2010
P.O. Box 47 , Bokhira , Porbandar, INDIA
16 J - - 04 Lobster
Date Published: 01/20/2010
16 J - - 06 Spiny Lobster, Rock Lobster
Date Published: 01/20/2010
Haravati Ice and Cold Storage
Date Published : 09/18/2009
Fish Market Porbandar , Gujarat, GJ INDIA
16 J - - 04 Lobster
Date Published: 09/18/2009
16 J - - 06 Spiny Lobster, Rock Lobster
Date Published: 01/20/2010
King Fisheries (aka King Intl Aquamarine) Private Limited
Date Published : 09/18/2009
Neendakara P.O. Chavara , Quilon, Kerala Estate INDIA
16 J - - 04 Lobster
Date Published: 09/18/2009
16 J - - 06 Spiny Lobster, Rock Lobster
Date Published: 01/20/2010
Ravi Fisheries Pvt Ltd (Ravi Fish Industries Pvt Ltd)
Date Published : 09/18/2009
Plant 2, B-36 , Wagle Industrial Estate , Thane, Maharashtra INDIA
16 J - - 04 Lobster
Date Published: 09/18/2009
16 J - - 06 Spiny Lobster, Rock Lobster
Date Published: 01/20/2010
Sawant Food Products
Date Published : 09/18/2009
78 Regent Chambers , Mumbai, INDIA
16 J - - 04 Lobster
Date Published: 09/18/2009
16 J - - 06 Spiny Lobster, Rock Lobster
Date Published: 01/20/2010
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