Inspections, Compliance, Enforcement, and Criminal Investigations
Nick & Katie's, Inc 9/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
September 13, 2012
WARNING LETTER NO. 2012-NOL-30
UNITED PARCEL SERVICE
Delivery Signature Requested
Ronald J. Ruffino, Co-Owner
Nick & Katie’s, Inc.
6845 Louis XIV Street
New Orleans, Louisiana 70124
Dear Mr. Ruffino:
On May 16, 17, 22, 30, June 1, and 5, 2012, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 5323 Franklin Avenue, Suite A, New Orleans, Louisiana. We found you continue to have serious deviations from FDA's Low-Acid Canned Food regulations, Title 21, Code of Federal Regulations, Parts 108 and 113, (21 CFR 108 and 113) and Acidified Foods regulations, 21 CFR108 and 114, and with applicable parts of the Current Good Manufacturing Practice (CGMP) provisions in 21 CFR 110. Failure to comply with all of the requirements of 21 CFR 108.25 and 108.35, and the mandatory portions of Parts 113 and 114, constitutes a prima facie basis for the immediate application of the emergency permit control provisions of Section 404 of the Food Drug and Cosmetic Act (the Act). In addition, such failure renders your acidified food adulterated within the meaning of Section 402(a)(4) of the Act [21 United States Code (USC) 342(a)(4)]. Accordingly, your acidified foods are adulterated because they have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Foods regulations through links on FDA's Internet home page at http://www.fda.gov.
We received your response dated June 26, 2012, concerning our investigator’s observations noted on the FORM FDA 483 (FDA 483), List of Inspectional Observations, issued to you on June 5, 2012. Our evaluation of your response is discussed after each significant violations listed on the FDA 483, but are not limited to, the following:
1. Your firm failed to file a scheduled process for the acidified food manufactured by your firm. Specifically, at this time, there are no acidified food scheduled processes filed with FDA for your firm’s Olive Salad product. As a commercial processor engaged in the thermal processing of acidified foods you must, no later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes, including conditions for heat processing; control of pH, salt, sugar; preservative levels; and, source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).
Scheduled process information for acidified foods must be submitted on FORM FDA 2541a (Food Process Filing For All Methods Except Low-Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm.
In addition, your firm failed to register with FDA as a commercial processor of acidified foods. A commercial processor of acidified foods is required, no later than 10 days after first engaging in the manufacture, processing, and packing of acidified foods, to register and file a FORM FDA 2541 with FDA, as required by 21 CFR 108.25(c)(1).
2. Your firm failed to establish a scheduled process for your acidified food product by utilizing a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83. Specifically, your firm does not have scheduled processes established by an acidified foods expert for your acidified Olive Salad product.
According to your firm’s response, you intend to reformulate your Olive Salad to use (b)(4) in place of your low-acid canned black olives. Although we agree that this change in formulation will potentially exclude your (b)(4) from the Acidified Foods regulations (21 CFR 108 and 114), you have not provided any analytical data in terms of pH and water activity supporting this corrective action. In addition, you have not addressed the safety of the Olive Salad product in distribution channels in terms of providing evidence that all finished lots had a final equilibrium pH of 4.6 or below.
3. You failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pest, in accordance with 21 CFR 110.35(c). Specifically, a live fly was observed in the processing area and dead flies and insects were observed in glue traps in a window approximately six feet from food and processing equipment.
You explained in your written response you will consult with a licensed pest control operator to recommend an effective plan to control the entry of flies into the plant and eliminate flies that enter into your facility. You failed to provide the specific steps you are taking or a date by which you will implement these actions.
We also found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR 123, and the CGMP regulation for foods, 21 CFR 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 to comply with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act, [21 USC Section 342(a)(4)]. Accordingly, your seafood products are adulterated, because 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 & Controls Guidance through links on FDA’s Internet home page at www.fda.gov.
Other significant violations listed on the FDA 483 dated June 5, 2012, include, but are not limited to, the following:
4. You must conduct a hazard analysis to determine whether there are food safety hazards which are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for (b)(4) does not list the critical control point of thawing (b)(4) under refrigeration for controlling the food safety hazard of Clostridium botulinum (C. botulinum)toxin formation.
You explained in your written response you have revised your HACCP plan to include the additional critical control point at the thawing step; however, you did not provide your HACCP plan.
5. You must have a HACCP plan that, at a minimum, lists the critical limit which 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, your firm’s HACCP plan for crabmeat or crawfish stuffing lists a critical limit, “(b)(4) cooling time: Not more than (b)(4)”, at the “(b)(4)” critical control point, which is not adequate to control pathogen growth and toxin formation. Processing employees handle the crabmeat and crawfish stuffing immediately after it is cooked. The product exposure time at internal temperatures above 50 oF but below 135oF for products handled warm should be limited to a cumulative time of four hours, as long as no more than one of those hours is above 70oF.
You explained in your written response you have revised your HACCP plan to control pathogenic bacteria growth and toxin formation during the cooling process because of handling. You did not provide your HACCP plan; therefore, we could not evaluate your revisions.
6. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm’s HACCP plan for crabmeat or crawfish stuffing lists a monitoring procedure/ frequency at the “(b)(4)” critical control point that is not adequate to control pathogen survival. Specifically, the HACCP plan lists instructions to monitor the “(b)(4)”, but does not list a time value at that cooking critical control point. In addition, the monitoring procedure at the “(b)(4)” critical control point list a frequency of “(b)(4)”; however, you routinely store that product in a cooler overnight and on weekends when no one is physically at your firm.
You explained in your written response you have revised your HACCP plan to include the additional critical control point; however, you did not provide your HACCP plan.
7. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for crabmeat or crawfish stuffing at the “(b)(4)” and “(b)(4)” critical control points to control pathogen growth and toxin formation is not appropriate. The HACCP plan does not address correcting the causes of the deviations from the critical limits.
You explained in your written response you have revised your HACCP plan to include instructions to include identifying and correcting the causes of deviations to critical limits; however, you did not provide your HACCP plan.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating. You provided actions to correct additional deviations regarding the sanitary operations of your processing facility. For example: you removed the peeling paint near the processing equipment; and, you retrained your employees to wear hair nets.
This letter offers you an opportunity to meet with the FDA New Orleans District staff. We believe a meeting may assist you in resolving your firm’s lack of compliance with federal regulations. A meeting would provide an opportunity for you to present any questions you may have regarding the implementation of corrections and for the FDA to provide guidance and sources of training to assist you in achieving full compliance.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information which would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the CGMP regulation (21 CFR 110). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1290, extension 1103.
Patricia K. Schafer
New Orleans District
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