Skip page top navigation FDA Logo--links to FDA home
page Logo of and Link to start page of Office of Regulatory Affairs, 
U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

IA #16-23 - Revised 07/09/96, Attachment - 5/1/92


SUBJECT   :    "***Detention Without Physical Examination ***of Fresh and
               Frozen Lobster/Lobster Tails from India"

TYPE OF ALERT: ***Detention Without Physical Examination***

               Note: This is alert is being revised to provide changes to
               format and/or terminology and are bracketed by asterisks
               (***).

               ***(NOTE:  This import alert contains guidance to FDA field
               personnel only. It does not establish any requirments, or
               create any rights or obligations on FDA or on regulated
               entitie.)***

PRODUCT    :   Fresh or Frozen Lobster/Lobster Tails

PRODUCT CODE : 16J__04

PROBLEM    :   Decomposition (MSDC)

COUNTRY    :   India (IN, 455)

MANUFACTURER/
SHIPPER    :   N/A

IMPORTER'S
ID#        :   N/A

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)."]

RECOMMENDING
OFFICE     :   Division of Import Operations and Policy (HFC-170)

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 exempt list
               (Castlerock Seafoods and Sawant Food Products).

               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 on
               the attachment.  If a sufficient number of violative samples
               are noted for exempt firms, recommend to DIOP that these firms
               be removed from exempt status.




               Audit of private laboratory results which are negative for
               decomposition is also recommended.

               ***For questions or issues concerning science, science policy,
               sample collection, analysis, preparation, or analytical
               methodology, contact the Division of Field Science at (301)
               443-3320 or 3007.***

KEYWORDS   :   Lobster, Tails, Decomposition

FOI        :   No purging is required

PREPARED
BY         :   Linda Wisniowski, DIOP, (301) 443-6553

Attachment - Import Alert #16-23                       5/1/92

          Packers Excluded from Detention Without Physical Examination

Alsa Marine & Harvests
10 Taylors Road
Kilpauk, Chennai 600010
India

Amulya Sea Foods
166-A North Beach Road
Tuticorin, India

Castlerock Seafoods Pvt. Ltd.
203 Dalamil Chambers
New Marine Lines
Bombay, India 400020

Cham ice and Cold Storage
(a/k/a Cham Marine Products Pvt. Ltd.)
(a/k/a Cham Trading Organization)
Porbandar, India

Haravati Ice and Cold Storage
Fish Market Porbandar
Gujarat, India 360575

King Fisheries, Ltd.
Cochin, India

Ravi Fisheries Pvt. Ltd.
(Ravi Fish Industries Pvt. Ltd.)
Bombay, India

Sawant Fisheries Pvt. Ltd.
(Sawant Food Products Ltd.)
Bombay, India