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WARNING LETTER

Delfino Battista SRL MARCS-CMS 584077 —


Delivery Method:
Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Amedeo Giuseppe Battista
Recipient Title
Owner/CEO
Delfino Battista SRL

Gioacchino Rossini N. 1
Montecorvino Pugliano
84090 SA
Italy

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740-3835
United States



WARNING LETTER
Reference# 584077

July 2, 2019

Dear Mr. Battista:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Delfino Battista SRL, located at Gioacchino Rossini N. 1, Montecorvino Puglia no, Salerno, 84090, Italy on February 22-25, 2019. 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 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, lnspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response to the FDA-483 sent via email on March 19, 2019. Your response included a written description of corrections, revised HACCP plans entitled "Anchovies in Oil Production", "Production Anchovies Salted From fresh product" and "Production Anchovies Salted From Semi processed", and other HACCP related documents. However, our evaluation of your response revealed it was not adequate, 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 anchovy products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

Your significant deviations 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 revised HACCP plans, dated March 1, 2019, provided with your response for your anchovy products entitled "Anchovies in Oil Production", "Production Anchovies Salted From fresh product" and "Production Anchovies Salted From Semiprocessed" do not list critical control points for in-process refrigerated storage (i.e., storage period occurring while products are in-process), to control pathogen growth and toxin formation including Clostridium botulinum (C. botulinum) in your uneviscerated fish. After receiving fresh uneviscerated fish and fish which are salted and eviscerated, (b)(4); however, you do not have this listed in your plan as critical control points with appropriate monitoring procedures, recordkeeping, etc. Pathogen growth and toxin formation, including C. botulinum in your uneviscerated fish, is reasonably likely to occur if the fish is stored under inadequate temperatures.

Therefore, FDA recommends this refrigerated storage step be listed as a critical control point with a critical temperature limit of below 38°F (3.3°C) refrigeration temperature to control non-proteolytic C. botufinum in the uneviscerated fish. To control pathogen growth and toxin formation in the salted, eviscerated fish, FDA recommends a critical temperature limit of below 40°F (4.4°C). Furthermore, the refrigeration temperature should be measured using a continuous temperature-recording device, with a visual check of the recorded data at least once per day.

In addition, we note that our investigator observed the refrigeration unit that was storing raw uneviscerated fish and semi-finished anchovies at (b)(4)°C ((b)(4)°F), which is above FDA's recommendation of below 38°F (3.3°C) for uneviscerated fish and below 40°F (4.4°C) for salted, eviscerated fish. Furthermore, review of temperature monitoring records revealed several temperatures found to be above (b)(4)°C ((b)(4)°F) and as high as (b)(4)°C ((b)(4)°F) in 2018.

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 revised HACCP plans, dated March 1, 2019, provided with your response for your anchovy products entitled "Anchovies in Oil Production", "Production Anchovies Salted From fresh product" and "Production Anchovies Salted From Semiprocessed" list critical limits that are inadequate to control the identified food safety hazards. Specifically,

a. The receiving critical control points in all three of your HACCP plans for your anchovy products list a critical limit of "(b)(4)." This critical limit is inadequate to control scombrotoxin (histamine) formation and pathogen growth and toxin formation. FDA recommends a critical limit that lists fish are to be completely surrounded by ice during transit and at the time of delivery.

b. The "(b)(4)" critical control points in all three of your HACCP plans for your anchovy products identify the hazard "(b)(4)" but does not include a critical limit to control undeclared allergens. FDA recommends that the critical limit lists all major food allergens in the product formulation on all finished product labeling.

c. For the "Production Anchovies Salted From Fresh Product" HACCP plan, your receiving critical control point lists critical limits that are not adequate to control the hazard of histamine formation when receiving fresh uneviscerated anchovies. FDA recommends sensory examination, taking internal temperatures, and controls for either harvest vessel records or histamine testing with a limit of less than 50 ppm histamine as critical limits.

d. For the "Production Anchovies Salted From Fresh Product" HACCP plan, you do not list controls for the hazard of preformed botulinum toxin in fresh uneviscerated anchovies. FDA recommends a critical limit that requires the uneviscerated fish be five inches or less (from head to tail) and that the fish be boiled for at least 10 minutes to denature preformed C. botulinum toxin before processing (e.g ., evisceration, brining, etc.). You may choose to control preformed botulinum toxin at the receiving critical control point or as a separate critical control point.

e. For the "Production Anchovies Salted From Fresh Product" HACCP plan, the "(b)(4)" critical control point lists a critical limit of "(b)(4)%" for "(b)(4)". This is not adequate to control C. botulinum growth and toxin formation during maturation at ambient temperatures of (b)(4)C ((b)(4)°F) for (b)(4) months. FDA recommends that the critical limits list the critical factors for brining/maturation as established by a scientific study that are necessary to ensure that the finished product has a water phase salt level of 20% or higher that is achieved within 2 hours. As an alternative to measuring the critical factors, the water phase salt level of the finished product for each batch can be analyzed and recorded. Additionally, if anchovies are received already salted to a water phase salt level of 20% or higher by a previous processor, then the water phase salt level should be verified by documentation from the previous processor or by testing upon receipt. Furthermore, if these products are further processed in a manner that could reduce the salt levels (e.g., removal of brine, washing in water, filleting and packing in oil), then finished product testing should also be done.

3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your listed corrective actions for your anchovy products are not appropriate because they do not ensure that adulterated product does not enter commerce. When processors include corrective actions in their HACCP plan, the corrective actions must ensure that no adulterated product enters commerce as a result of a deviation and the cause of the deviation is corrected.

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 specifica lly, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, process flow diagrams, hazard analysis, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.htmI.

Based on our review of your FDA-483 response, we have the following comment. Your revised HACCP plans for anchovy products do not include all of the required contents of a HACCP plan, as required by 123.6(c). Specifically, the HACCP plans do not list verification procedures for each critical control point.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

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. 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 re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). 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.

You should direct your written reply to Sheena Crutchfield, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Crutchfield via email at Sheena.Crutchfield@fda.hhs.gov. Please reference# 584077 on any submissions and on the subject line of any emails to us.

Sincerely,

/S/

William A. Correll
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition