What's for Dinner Tonight?
(Verbatim • Factory Food)
(One in a continuing series of communiques relating to the American Food Distribution System)
WARNING LETTERSeptember 24, 2008
Le Huynh, President
Fulton Seafood Inc.
2818 McKinney St
Houston, Texas 77003-3732Dear Ms. Huynh:
We inspected your seafood importer establishment, located at 2818 McKinney St, Houston, Texas, on June 13, 16 & 17, 2008. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation…
…Additionally, your Canned Sardines in Tomato Sauce product will be considered adulterated under Section 402(a)(4) of the Act (21 U.S.C. ยง 342(a)(4)), in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health…
Your significant violations were as follows:
…Your firm uses the foreign manufacturer’s HACCP plan as an affirmative step, which appears to be inadequate to assure that the products are not adulterated. Specifically, the HACCP plan provided by the manufacturer, [blanked out] located in [blanked out] lacks information on the steps needed to control histamine formation during the raw material storage step.
Additionally, the HACCP manual does not contain a written guarantee from the foreign processor of the canned Sardines in Tomato Sauce.
FDA also collected a sample from this processor that was offered for entry in Houston, TX by your firm on April 01, 2008, under entry # [blanked out]. The sample collected by FDA personnel on April 15, 2008 was found violative for Histamines in three subsamples (Sub-sample: #8:131.0 ppm; #9:248.5 ppm; #12:124.7 ppm) and subsequently detained on May 15, 2008. The entry was refused admission on June 05, 2008.
Both our inspection and the above sample collected under entry number [blanked out], indicate that the foreign firm’s HACCP plan is inadequate to control Histamines.
We may take further action if you do not promptly correct these violations…
Sincerely,
Robert J. Deininger
District Director
Southwest Import District
I am pretty certain we can all rest assured no one purchased or ate any canned Sardines in Tomato Sauce between April 15, when FDA inspectors found some that were laced with histamines (the most common cause of food poisoning in fish) and Sept. 24, when the company no doubt immediately took more samples of its product to determine histamine levels and tossed out all offending batches.
→ B.Dunn, Jan 07, 2009, 05 16 am
