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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Louisa Food Products Inc 5/13/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Kansas City District
Southwest Region
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
 
Telephone:    (913) 495-5100

 

May 13, 2014
 
WARNING LETTER
 
UPS
 
CMS# 429248
 
Mr. Thomas J. Baldetti, General Manager,
Louisa Food Products, Inc.
1918 Switzer Ave
Saint Louis, MO 63136-3756
 
Dear Mr. Baldetti:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility located at 1918 Switzer Ave, Saint Louis, MO 63136-3756, April 7, 2014 through April 22, 2014. During the inspection, our investigator observed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 &110).  In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise fail to operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated within the meaning of Section 402(a){4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.§ 342(a)(4)]. Accordingly, your seafood products 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, FDA regulations, and the Fish and Fisheries Product Hazards & Controls Guidance: 4th Edition (the Hazard Guide) through links on FDA's home page at www.fda.gov.
 
We acknowledge the letter dated April 29, 2014 you sent this office in response to our investigator's observations listed on the Form FDA-483. The agency has reviewed your response and we continue to have concerns because you have not provided any detailed evidence or documentation for many of your reported corrections.
 
Your significant violations were as follows:
 
1.  You must conduct or have conducted, for you, a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c).
 
A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However,
 
a.  Your firm's HACCP plan for Lobster, Shrimp, and Scallops containing pasta does not identify the food safety hazard of Clostridium botulinum growth and toxin formation for fish and fishery ingredients received raw and frozen in reduced oxygen packaging.
 
b.  Your firm's HACCP plans for Lobster, Shrimp, and Scallops containing pasta and Salmon containing pasta does not identify the food safety hazard of metal fragments in products containing vegetables chopped by the (b)(4).
 
c.   Your firm's HACCP plan for Lobster, Shrimp, and Scallops containing pasta and Salmon containing pasta does not identify the food safety hazard of undeclared seafood (fin fish, crustaceans, and shell fish) allergens. FDA recommends that firms include a critical control point in their plans to monitor each batch of labels for the declaration of all allergenic substances, including the appropriate fish species, on each product label.
 
2.  You must have a HACCP plan that lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However,
 
a.   Your firm's HACCP plans for lobster, shrimp, scallops, and salmon do not list critical limits at the "Cooking, (Heat Process)" Critical Control Point to control for identified hazard "Microbiological Pathogens" including"Listeria."
 
The critical limits your plan lists are (b)(4) degrees [Fahrenheit] internal temperature" for lobster, shrimp, and scallop products and (b)(4) degrees [Fahrenheit] internal temperature" for salmon products. This is insufficient to control for the identified hazard because there is no time element to the critical limit. FDA recommends for control of Listeria monocytogenes that firms achieve a 6 log reduction(6D) in the number of organisms. This can be achieved by heating the product to 160 degrees Fahrenheit and holding it for 1.5 minutes or heating the product to 145 degrees Fahrenheit and holding it for 17 minutes. For more information, see Appendix 4 of the Hazard Guide.
 
b.  Your firm's HACCP plan for lobster, shrimp, scallops, and salmon does not list critical limits at the Cooling of All Non-USDA Critical Control Point to control for the identified hazard "Microbiological Pathogens" including "Clostridium Perfringens."
 
The critical limits your plan lists are "Chill from (b)(4) F- (b)(4) F in (b)(4)." This is not sufficient to control for Clostridium perfringens.  The time spent between 125 F and 70 F must be more strictly controlled. FDA recommends food is kept between
125 F and 70 F for less than 2 hours to control for this hazard. Please refer to table A-2 on page 421 of the Hazard Guide for information about controlling for pathogen growth and toxin formation in fish and fishery products
 
3.  You must have a HACCP plan which lists verification procedures and frequencies thereof that you will use in accordance with 21 CFR 123.8(a) to comply with 21 CFR 123.6(c)(6). One of the verification procedures required by 21 CFR 123.8(a) is the calibration of process­ monitoring instruments. However, your HACCP plans for Lobster, Shrimp, and Scallops; Salmon; and Cooling of All Non-USDA product lacks requirements for documentation of the calibration and the frequency of calibration of the stem thermometers you use to monitor the cooking process and the thermometers you use to monitor the cooling process. The Hazard's Guide recommends calibrating temperature-recording devices against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device.
 
4.  You are failing to monitor sanitation conditions and practices with sufficient frequency to ensure conformance with those conditions and practices specified in 21 CFR part 110 in violation of 21 CFR123.11(b) as evidenced by:
 
a.   A sink used for washing celery used in seafood pasta products lacks a backflow prevention device.
 
b.  A lack of a backflow-prevention device on your (b)(4) gallon cook kettle. (b)(4) gallon cook kettle lacks a sufficient air gap. Both kettles are used to cook seafood pasta products.
 
c.  Deteriorating hoses and ceilings in the manufacturing area above exposed seafood product.
 
d.  Open dumpster with flying insect pests adjacent to the manufacturing area for seafood pasta. 
 
5.  You failed to maintain your physical facility in a sanitary condition, as required by 21 CFR 110.35(a). Specifically, sliced mushrooms used in the manufacture of Louisa Mushroom Ravioli Jumbo Round were stored exposed under a dust-covered conduit in your meat­ thawing cooler.
 
6.  You must have a HACCP plan that lists each location where you process fish and fishery products and identifies each kind of fish and fishery product you process to comply with 21 CFR123.6(b). However, your HACCP plan for Lobster, Shrimp and Scallops; HACCP plan for Salmon and HACCP plan for Cooling of All Non-USDA product do not identify the locations where you process. Your HACCP plan for cooling fish and fishery product after cooking does not identify the products it covers.
 
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
 
You may find the Act and the FDA's regulations through links on FDA's home page at http://www.fda.gov.
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. Sections 304 and 302 of The Act authorizes the seizure of adulterated and misbranded products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 332 and 334].
 
Additionally, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. Are-inspection is conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re­ inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)].  For a foreign facility, FDA will assess and collect fees for re-inspection related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
 
Your response should be sent to U.S. Food and Drug Administration, Dr. Ann Adams, Acting District Director at the address noted above. If you have any questions with regard to this letter, Compliance Officer Matthew R. Sleeter can be reached at (913) 495-5151 or email Matthew.Sleeter@fda.hhs.gov
  
 
Sincerely,
/S/ 
Dr. Ann Adams
Acting Director, Kansas City District