Import Alert 16-114
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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 # 16-114
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Frozen Shrimp Imported By Sigma International, Inc., St. Petersburg, Florida"
Reason for Alert:
Orlando district has documented the following import practices of Sigma International related to frozen shrimp:
1. Repeatedly importing violative products. Recently three shipments of shrimp were sampled by FDA and found violative for decomposition. All three shipments were submitted for seizure. In addition, FDA analysis of a shipment of shrimp imported by Sigma, identified with sample number 1893130, found the product violative for filth (cockroach excreta, human hair). Another shipment imported by Sigma, identified with sample number 1893171, was subject to detention, without physical examination, because of Salmonella, filth, and decomposition.
The entry documents submitted with that shipment failed to correctly identify the source of the shrimp as being shipped by a firm on detention without physical examination.
2. Submitting entry documents that do not correctly identify the manufacturer or shipper. In the cases cited above (FDA sample numbers 1893130 and 1893171), the entry documents incorrectly listed packers that were not subject to detention, without physical examination, at the time of entry. The actual packers of the products were subject to detention, without physical examination, under Import Alert #16-35, "Fresh and Frozen Shrimp from India."
Orlando district has identified three shipments of shrimp imported by Sigma which have recently been submitted for seizure because of decomposition (see above). All three lots were entered through Los Angeles district and the entry documents identified firms other than the actual packers (who were subject to detention without physical examination). This resulted in Los Angeles district releasing, rather than detaining without physical examination, the shipments. Prior to accomplishments of the seizures, Sigma made continued attempts to sell the decomposed shrimp which has been partially or totally rejected by eight consignees and the National Marine Fisheries Service (NMFS).
3. Laboratory Shopping (i.e., sending samples of products detained without physcal examination to different private labs and then submitting to FDA only the analyses that show the product to be in compliance, even though another lab found the product violative.)
Orlando district has documented this practice for at least two entries, where one laboratory found the entries violative for Salmonella and Sigma only submitted results from a laboratory that obtained negative results. Due to this practice it is difficult to determine whether the appearance of a violation in Sigma entries has been overcome.
4. There has been an abrupt drop-off of entries by Sigma in Orlando district ports since February 1994. The firm may be entering products through other ports and/or under alternate names. Recent entries of frozen shrimp through Los Angeles have reportedly identified other firms, such as a bank, as the importer of record.
Based on the above shrimp imported by Sigma appears violative for filth, decomposition, and Salmonella. Further the source of the shrimp may not be properly identified on the shipping documents, permitting the shipments to avoid detention without physical examination and/or close scrutiny by FDA.
1. Repeatedly importing violative products. Recently three shipments of shrimp were sampled by FDA and found violative for decomposition. All three shipments were submitted for seizure. In addition, FDA analysis of a shipment of shrimp imported by Sigma, identified with sample number 1893130, found the product violative for filth (cockroach excreta, human hair). Another shipment imported by Sigma, identified with sample number 1893171, was subject to detention, without physical examination, because of Salmonella, filth, and decomposition.
The entry documents submitted with that shipment failed to correctly identify the source of the shrimp as being shipped by a firm on detention without physical examination.
2. Submitting entry documents that do not correctly identify the manufacturer or shipper. In the cases cited above (FDA sample numbers 1893130 and 1893171), the entry documents incorrectly listed packers that were not subject to detention, without physical examination, at the time of entry. The actual packers of the products were subject to detention, without physical examination, under Import Alert #16-35, "Fresh and Frozen Shrimp from India."
Orlando district has identified three shipments of shrimp imported by Sigma which have recently been submitted for seizure because of decomposition (see above). All three lots were entered through Los Angeles district and the entry documents identified firms other than the actual packers (who were subject to detention without physical examination). This resulted in Los Angeles district releasing, rather than detaining without physical examination, the shipments. Prior to accomplishments of the seizures, Sigma made continued attempts to sell the decomposed shrimp which has been partially or totally rejected by eight consignees and the National Marine Fisheries Service (NMFS).
3. Laboratory Shopping (i.e., sending samples of products detained without physcal examination to different private labs and then submitting to FDA only the analyses that show the product to be in compliance, even though another lab found the product violative.)
Orlando district has documented this practice for at least two entries, where one laboratory found the entries violative for Salmonella and Sigma only submitted results from a laboratory that obtained negative results. Due to this practice it is difficult to determine whether the appearance of a violation in Sigma entries has been overcome.
4. There has been an abrupt drop-off of entries by Sigma in Orlando district ports since February 1994. The firm may be entering products through other ports and/or under alternate names. Recent entries of frozen shrimp through Los Angeles have reportedly identified other firms, such as a bank, as the importer of record.
Based on the above shrimp imported by Sigma appears violative for filth, decomposition, and Salmonella. Further the source of the shrimp may not be properly identified on the shipping documents, permitting the shipments to avoid detention without physical examination and/or close scrutiny by FDA.
Guidance:
Districts may detain, without physical examination, all shipments of frozen shrimp imported by, consigned to, or invoiced to Sigma International, Inc., St. Petersburg, Florida. Because of the recent reported use of firms such as banks as the importer of record for frozen shrimp, entry documents should be closely reviewed to determine whether a relationship exists with Sigma.
NOTE: At the request of FDA, USCS has implemented ACS screening criteria placing all shrimp from Sigma (and related firms) on intensive examination. We have requested that local USCS officials notify their local FDA counterparts whenever a shipment from Sigma is encountered. Upon notification, districts should check EEPS records to determine the status of the shipment. Districts should request paper documentation for shipments identified for review. If a May Proceed notice has been authorized by EEPS, districts must immediately notify the filer that a May Proceed notice was issued in error and request paper documentation for FDA review. Districts must then notify their local USCS official so that the intensive examination requirement can be rescinded.
Because of the documented practice of "laboratory shopping" by Sigma, districts are advised that samples collected directly by Sigma and submitted to a private laboratory for analyses should not be considered sufficient to remove the appearance of a violation. Therefore, where Sigma seeks to overcome the appearance of a violation, by submitting laboratory analysis, third party sampling should be used. In addition, procedures should be implemented to assure that only one sample is collected for private laboratory analysis.
NOTE: At the request of FDA, USCS has implemented ACS screening criteria placing all shrimp from Sigma (and related firms) on intensive examination. We have requested that local USCS officials notify their local FDA counterparts whenever a shipment from Sigma is encountered. Upon notification, districts should check EEPS records to determine the status of the shipment. Districts should request paper documentation for shipments identified for review. If a May Proceed notice has been authorized by EEPS, districts must immediately notify the filer that a May Proceed notice was issued in error and request paper documentation for FDA review. Districts must then notify their local USCS official so that the intensive examination requirement can be rescinded.
Because of the documented practice of "laboratory shopping" by Sigma, districts are advised that samples collected directly by Sigma and submitted to a private laboratory for analyses should not be considered sufficient to remove the appearance of a violation. Therefore, where Sigma seeks to overcome the appearance of a violation, by submitting laboratory analysis, third party sampling should be used. In addition, procedures should be implemented to assure that only one sample is collected for private laboratory analysis.
Product Description:
Shrimp
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous or deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)]"
OASIS charge code - SALMONELLA
and
Filth, Decomposition:
"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, namely that it appears to contain rodent filth, insect filth, and decomposition, among other substances. [Adulteration, Section 402(a)(3)]"
OASIS charge code - FILTHY
OASIS charge code - SALMONELLA
and
Filth, Decomposition:
"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, namely that it appears to contain rodent filth, insect filth, and decomposition, among other substances. [Adulteration, Section 402(a)(3)]"
OASIS charge code - FILTHY
UNITED STATES
Sigma International, Inc.
Date Published : 09/10/2009
10901 Roosevelt Blvd N Ste 100b , St Petersburg, FL 33716-2305 UNITED STATES
16 J - - 05 Shrimp & Prawns
Date Published: 02/04/2010
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