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  3. <wcm:element name="MainContent">&lt;table cellspacing="0" cellpadding="0" width="100%" border="0"&gt;&lt;tbody&gt;&lt;tr&gt;&lt;td valign="middle"&gt;&amp;nbsp;&lt;/td&gt;&lt;td valign="bottom"&gt;&amp;nbsp;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td valign="middle" width="67%" height="63"&gt;&lt;h3 style="font-weight: bold; font-size: 0.8em; color: #000080; background-color: #ffffff; text-align: left"&gt;&lt;img alt="Department of Health and Human Services logo" border="0" src="[!--$wcmUrl('resource','groups/fdagov-public/documents/image/ucm113123.gif')--]" /&gt;Department of Health and Human Services&lt;/h3&gt;&lt;/td&gt;&lt;td valign="bottom" width="33%"&gt;Public Health Service&lt;br /&gt;Food and Drug Administration&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td valign="middle"&gt;&amp;nbsp;&lt;/td&gt;&lt;td valign="top"&gt;Detroit District&lt;br /&gt;300 River Place&lt;br /&gt;Suite 5900&lt;br /&gt;Detroit, MI 48207&lt;br /&gt;Telephone: 313-393-8100&lt;br /&gt;FAX: 313-393-8139&lt;/td&gt;&lt;/tr&gt;&lt;/tbody&gt;&lt;/table&gt;&lt;p style="text-align: center"&gt;&lt;strong&gt;&lt;br /&gt;WARNING LETTER&lt;/strong&gt;&lt;br /&gt;2010-DET-01&lt;/p&gt;&lt;p&gt;&lt;br /&gt;October 15, 2009&lt;/p&gt;&lt;p&gt;&lt;br /&gt;&lt;strong&gt;VIA FEDERAL EXPRESS&lt;/strong&gt;&lt;/p&gt;&lt;p&gt;&lt;br /&gt;Leo D. LaRose, President&lt;br /&gt;Cold Cut Kruise, Inc.&lt;br /&gt;39916 Jason Court&lt;br /&gt;Novi, Michigan 48375&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p&gt;Dear Mr. LaRose:&lt;/p&gt;&lt;p&gt;We inspected your seafood processing facility, located at 39916 Jason Court, Novi, Michigan on&lt;br /&gt;June 23 - July 8, 2009. We found that you have serious violations of the seafood Hazard&lt;br /&gt;Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations,&lt;br /&gt;Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of&lt;br /&gt;Federal Regulations, Part 110 (21 CFR 123 &amp;amp; 110). In accordance with 21 CFR 123.6(g),&lt;br /&gt;failure of a processor of fish or fishery products to have and implement a HACCP plan that&lt;br /&gt;complies with this section or otherwise operate in accordance with the requirements of Part 123,&lt;br /&gt;renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the&lt;br /&gt;Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. &amp;sect; 342(a)(4). Accordingly, your tuna&lt;br /&gt;salad and tuna salad sandwiches are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards &amp;amp; Controls Guidance through links in FDA's home page at www.fda.gov.&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p&gt;Your significant violations were as follows:&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p style="margin-left: 20px"&gt;1. You must conduct or have conducted for you a hazard analysis for each kind of fish and&lt;br /&gt;fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your fim1 does not have a HACCP plan for tuna salad and tuna salad sandwiches to control the food safety hazards of histamine formation and pathogen growth.&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p style="margin-left: 20px"&gt;For more information concerning the controls for histan1ine formation and pathogen growth,&lt;br /&gt;refer to Chapters 7 and 12, respectively, in the Fish and Fisheries Products Hazards &amp;amp;&lt;br /&gt;Controls Guidance.&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p style="margin-left: 20px"&gt;2. You must maintain sanitation control records that, at a minimum, document monitoring and&lt;br /&gt;corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your&lt;br /&gt;firm did not maintain any sanitation control records for the eight key areas of sanitation that&lt;br /&gt;document sanitation monitoring and correction of sanitation deficiencies for the tuna salad&lt;br /&gt;sandwiches manufactured at your firm.&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p&gt;We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.&lt;/p&gt;&lt;p&gt;You should respond in writing within fifteen (15) working days from your receipt of this letter.&lt;br /&gt;Your response should outline the specific things you are doing to correct these violations. You&lt;br /&gt;should include in your response documentation such as HACCP and verification records, or other&lt;br /&gt;useful information that would assist us in evaluating your corrections. If you cannot complete all&lt;br /&gt;corrections before you respond, you should explain the reason for your delay and state when you&lt;br /&gt;will correct any remaining violations.&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p&gt;This letter may not list all the violations at your facility. You are responsible for ensuring that&lt;br /&gt;your processing plant operates in compliance with the Act, the seafood HACCP regulation (2 I&lt;br /&gt;CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You&lt;br /&gt;also have a responsibility to use procedures to prevent further violations of the Act and all&lt;br /&gt;applicable regulations.&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p&gt;Please send your reply to the Food and Drug Administration, Attention: LCDR Anastasia M.&lt;br /&gt;Piliafas-Brown, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite&lt;br /&gt;5900, Detroit, Michigan, 48207. If you have questions regarding any issues in this letter, please&lt;br /&gt;contact LCDR Piliafas-Brown at (313) 393-8100.&lt;br /&gt;&amp;nbsp;&lt;/p&gt;&lt;p&gt;Sincerely,&lt;/p&gt;&lt;p&gt;/S/&lt;/p&gt;&lt;p&gt;Joann M. Givens&lt;br /&gt;District Director&lt;br /&gt;Detroit District Office&lt;/p&gt;</wcm:element>

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