- T & L Creative Salads, Inc.
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
May 26, 2015
WARNING LETTER NYK-2015-32
RETURN RECEIPT REQUESTED
Mr. Anthony L. Morello, Jr., President
T & L Creative Salads, Inc.
8802 Foster Avenue
Brooklyn, NY 11236-3211
Dear Mr. Morello, Jr.:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, T & L Creative Salads, Inc., located at 8802 Foster Avenue, Brooklyn, NY, between October 15, 2014, and October 27, 2014. During that inspection, we found that you had 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). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm.
We received your firm’s response letter to the FDA-483, Inspectional Observations, dated November 11, 2014. We acknowledge your firm has developed a HACCP plan for your tuna salad products including wraps packaged in oxygen-limiting containers to control the hazards of pathogenic bacteria growth and toxin formation including Clostridium botulinum, scombrotoxin (histamine) formation, and allergens; and you have developed a separate HACCP plan for your seafood salads including crab & shrimp wraps packaged in oxygen-limiting containers to control the hazards of pathogenic bacteria growth & toxin formation including Clostridium botulinum, metal inclusion, and allergens. However, our evaluation of your HACCP plans, revealed serious deviations, as further described in this letter.
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 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 refrigerated ready-to-eat (RTE) fishery products packed in oxygen-limiting containers including shrimp salad, shrimp wraps, crab wraps, lox cream cheese, seafood salad, tuna fish salad, tuna fish wraps, crab cakes, and shrimp cakes are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Your significant violations are as follows:
1) You must conduct a hazard analysis 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 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 your crab and shrimp cake products, dated November 1, 2014, does not list the critical control point of “Deep Frying” for controlling the food safety hazard of pathogenic bacteria growth and toxin formation. Specifically, you described to our investigator that you deep fry your cakes at approximately 400°F for 8 minutes to an internal temperature of 140°F. FDA considers the crab and shrimp cakes processed by your firm as ready-to-eat, as the product appears to be fully cooked. Therefore, FDA recommends you identify this step as a critical control point and set critical limits established by a scientific study for critical factors of the frying process (such as temperature of fryer, size of product, length of cook, etc.), or an end product internal temperature, which will ensure a minimum 6 log reduction of Listeria monocytogenes in all cooked units.
2) You must have a HACCP plan that, at a minimum, 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, your firm’s HACCP plans for your crab and shrimp cakes, seafood salad, and tuna fish salad products, dated November 1, 2014 list a critical limit of “pH is to be below 5” at the “Formulation blending” critical control point that is not adequate to control Clostridium botulinum. Specifically, your imitation crab and shrimp cakes are formulated, formed, coated with pasteurized egg and breadcrumbs, and then deep fried. Therefore, your critical limit should ensure that the finished product have a pH below 5, rather than just during the formulation blend processing step. In addition, since your HACCP plan for tuna fish salad includes the finished products of the tuna salad and tuna salad wraps that are made with additional ingredients, your HACCP plan should ensure that the pH is below 5 in both your tuna salad and tuna salad wraps finished products. Furthermore, your HACCP plan for seafood salad includes several different finished products of various seafood salads and seafood salad wraps; therefore, your critical limit should ensure that the finished products of salads and wraps have a pH below 5.
3) 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 plans for your crab and shrimp cakes, seafood salad, and tuna fish salad products, dated November 1, 2014, list monitoring procedures and frequencies at the following critical control points that are not adequate to control the identified food safety hazards.
a. Your monitoring procedure at the “Formulation blending” critical control point to control the hazard of Clostridium botulinum states “pH recorded for each batch.” FDA recommends you monitor pH of the finished product and collect a representative number of samples from each batch of finished product.
b. Your monitoring procedure at the “Processing” critical control point to control the hazard of pathogenic bacteria growth and toxin formation states “Time and Temperature will be logged for each batch.” Your firm should monitor the start and finish time of each batch, in addition to monitoring the time and internal temperature every two hours.
c. Your monitoring procedure at the “Stabilization” (i.e., cooling after cooking) critical control point to control the hazard of pathogenic bacteria growth and toxin formation states “monitor the chill down for each frying lot, using a hand held thermometer and record the temperature and time on the chill log.” FDA recommends you monitor the length of time of the cooling cycle using a clock, and monitor the internal temperature of the product using a temperature-indicating device (i.e., a thermometer) and a visual check on the time of cooling at least every two hours.
d. Your monitoring procedure at the “Labeling” critical control point to control the hazard of undeclared major food allergens states “At the start of each new item a designated employee will visually check the labels for all allergens.” FDA recommends that in addition to monitoring labels at the start of each new item, that you also either visually examine a label when new cases of label rolls are used or visually examine a representative number of finished labels from each lot of finished products.
4) Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plans listed in your firm’s HACCP plans for crab and shrimp cakes, seafood salad, and tuna fish salad products are not appropriate to control the identified hazards.
a. Your corrective action plan at the “Formulation blending” critical control point to control Clostridium botulinum lists “if pH is above 5 product will be checked, and records will be reviewed, if product is confirmed above pH of 5 it will be destroyed.” Based on the records reviewed, this corrective action does not provide sufficient detail with regards to what will be the accept or reject criteria. In addition, this corrective action does not ensure that that the cause of the deviation is corrected. Therefore, FDA recommends that in addition to destroying the product, you review and modify your process accordingly.
b. Your corrective action plan at the “Processing” critical control point for your crab and shrimp cakes, and seafood salad products to control pathogenic bacteria growth and toxin formation, lists “Chill and hold the affected product until an evaluation of the total time and temperature exposure is performed, if found out of compliance product will be destroyed.” However, your corrective action does not ensure that the cause of the deviation is corrected. FDA recommends that in addition to destroying the product, you modify the process as needed to reduce time and temperature exposure.
In addition, your corrective action plan for your tuna fish salad products to control pathogenic bacteria growth and toxin formation and scombrotoxin (histamine) formation lists “Chill and hold the affected product until an evaluation of the total time and temperature exposure is performed, if found out of compliance product will be destroyed” and “Perform Histamine analysis, destroy product if exceeds 50 ppm.” FDA recommends that histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot. In addition, to address the cause of the deviation, you modify the process as needed to reduce the time and temperature exposure to ensure that the cause of the deviation is corrected.
c. Your corrective action plan at the “Stabilization” critical control point for crab and shrimp cakes to control pathogenic bacteria growth and toxin formation lists “Modify the process as needed to reduce the time/temperature exposure and hold lot and evaluate time and temperature exposure destroy the lot if time above 40 degrees F exceeds 4 hours cumulatively if any of the time is above70 degrees F or if time above 40 degrees F exceeds 8 hours cumulatively as long as no portion of that time is above 70 degrees.” Your listed corrective action is inconsistent with your listed critical limits. For example, your critical limit allows a total of 6 hours for cool down to 41°F or less, while your corrective action allows 8 hours. If your products are not rapidly cooled, the potential for pathogenic bacteria growth and toxin formation is a reasonably likely hazard. An example of an acceptable corrective action is to destroy the product or divert the product to a non-food use. Evaluations of time and temperature exposures are not an option as a corrective action since the safe cumulative time/temperature exposures have already been exceeded.
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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. 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.
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. A re-inspection is one or more inspections 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 the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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.
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 Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: LCDR Catherine Beer, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contactLCDR Catherine Beerat 518-453-2314 x1015.
Ronald M. Pace
New York District
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