Inspections, Compliance, Enforcement, and Criminal Investigations
Kham Seafood Company 17-Oct-01
DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration
New Orleans District
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
October 17, 2001
WARNING LETTER NO. 2002-NOL-03
Mr. Ray P. Khemmanivanh, Owner
Kham Seafood Company
11125 Beverly Road
Irvington, Alabama 36544-2961
Dear Mr. Khemmanivanh:
On September 10-12, 2001, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your crabmeat processing facility, located at 11125 Beverly Road, Irvington, Alabama. The inspection was conducted to determine your firm?s compliance with FDA?s seafood processing regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and the Current Good Manufacturing Practice (CGMP) requirements for foods, 21 CFR 110. Our investigator documented numerous deviations, some of which were previously brought to your attention, that cause your crabmeat product to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (Act). You can find this Act and the seafood HACCP regulations through Internet links in FDA?s homepage at www.fda.gov.
During the inspection, the investigator collected samples of your cooked, ready-to-eat claw crabmeat. The samples were subsequently analyzed for the presence of microorganisms. You should be aware that Escherichia coli (E. coli) was recovered from one sample, collected on September 10, 2001, of the cooked, ready-to-eat claw crabmeat. You may already have received a letter from our Southeast Regional Laboratory in Atlanta, Georgia, notifying you of the same. The presence of E. coli causes your crabmeat to be in violation of Section 402(a)(3) of the Act.
E. coli is part of the normal intestinal flora of humans or other primates. The presence of E. coli in your crabmeat is an indication of fecal contamination. Some strains of E. coli cause food-borne bacterial illness such as gastroenteritis that can be a serious illness for some people; especially the elderly, newborns, and those with weakened immune systems. Food processors and handlers should take all precautions necessary to reduce the risk of contamination and to keep food safe from E. coli. We strongly recommend you determine the cause(s) of this problem and take corrective action as soon as possible.
The deviations from FDA?s seafood HACCP regulations were as follows:
. You must implement the monitoring procedures listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not record the crabmeat temperature during the backing, picking, and packing critical control points. In addition, your firm did not record the temperature of the cooler during the crab cooling critical control point. Your firm also did not record the observed cooking times at the crab cooking critical control point.
. You must adequately monitor sanitation conditions and practices during processing to comply with 21 CFR 123.1l(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces with sufficient frequency to ensure control as evidenced by numerous flies observed in the cooking/backing room and in both of the picking/packing rooms.
During the inspection, our investigator documented numerous insanitary conditions. The inspection found that you have not taken effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. Failure to exclude pests is a potential contributing factor to microbiological contamination. In addition, two cats were observed in the back dock area.
Employees working in direct contact with food and food contact surfaces did not take necessary precautions to protect against contamination of those items from microorganisms or foreign substances. For example, employees placed perforated containers filled with cooked crabs and crab claws directly on unsanitized stands during backing operations.
Given this, we expect you to notify this office in writing, within 15 days from your receipt of this letter, outlining specific actions you have taken to correct the deficiencies and to assure that such violations will not recur. Include copies of any available documentation, such as your revised HACCP plan, time and temperature monitoring records, or other records demonstrating that corrections have been made. If you cannot complete all corrections before you respond, we expect you will explain the reason for the delay and a deadline by which you will correct any remaining deficiencies.
This letter does not list all the deviations at your facility. A copy of the form FDA 483 that was discussed with you on September 12, 2001, is enclosed. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations, and CGMP?S for foods. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations. Failure to implement corrective action may result in regulatory action initiated by FDA without further notice. This action may include product seizure and/or injunction against you and your company.
Send your reply to Mark W. Rivero, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 253-4519.Sincerely,
Patricia K. Schafer
Acting District Director
New Orleans District Office