Inspections, Compliance, Enforcement, and Criminal Investigations
G.DiLullo & Sons 30-Mar-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
March 30, 2005
File # 05-NWJ-12
Mr. Ugo DiLullo
G. DiLullo & Sons
1004 Edgewater Avenue
Westville, NJ 08903
Dear Mr. DiLullo:
On January 26, 27 & February 1, 2005, the Food and Drug Administration (FDA) conducted an inspection of your low acid canned food (LACF) manufacturing facility, located at 1004 Edgewater Avenue, Westville, New Jersey. The inspection found that you have a serious deviation from the Seafood HACCP regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), the failure of a processor to have and implement a HACCP plan that complies with this section, or to otherwise operate in accordance with the requirements of Part 123 renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food Drug & Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)).
Similarly, a serious deviation from the regulations for thermally processed low acid foods in hermetically sealed containers (21 CFR 108.35 & 21 CFR Part 113) was also found by our investigators, causing your products to be adulterated within the meaning of Section 402(a)(4) of the Act. In addition, a temporary emergency permit (21 U.S.C. 344) may be required for low-acid foods in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR Part 108.35, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 113 (21 CFR 108.35(a)).
Accordingly, the deviations noted during the inspection cause your Snapper Turtle Soup and Brown Gravy to be adulterated within the meaning of section 402(a)(4) of the Act, in that it was prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find this Act, the seafood HACCP regulations and the regulations for thermally processed low acid foods in hermetically sealed containers through links in FDA's home page at www.fda.gov.
The deviations found were as follows:
You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a written 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)(1). 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, your firm's HACCP plan for Snapper Turtle Soup does not list the food safety hazard of pathogen growth and toxin formation. In the absence of temperature controls, significant handling of the turtle meat over extended time periods may present a food safety hazard associated with growth and toxin development from pathogenic microorganisms such as Staphylococcus aureus and Bacillus cereus.
Your firm failed to test the mercury-in-glass (MIG) thermometers on your retorts against a known accurate standard thermometer at least annually to ensure their accuracy, as required by 21 CFR 113.40(a)(1).
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.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these deviations. You should include in your response documentation such as revised HACCP plan(s), monitoring procedures, calibration records or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining deviations.
This letter may not list all deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act, the seafood HACCP regulations (21 CFR Part 123), the regulations for thermally processed low acid foods in hermetically sealed containers (21 CFR 108.35 & 21 CFR Part 113) and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
In addition to the Seafood HACCP violations discussed above, the FDA investigator(s) noted that the ingredient statement for your Snapper Turtle Soup did not accurately reflect the actual ingredients in the soup and that the ingredients were not listed in the order of predominance in the product, as required by Section 403(i) of the Act (21 U.S.C. § 343(i)). For example, the ingredient statement listed margarine, which is not in the product formulation, and did not list soybean oil and tomato sauce, which are in the product formulation. Additionally, the label did not identify the sub-ingredients of multi-ingredient components. We acknowledge that you were in the process of ordering new labels during the inspection.
However, we need to point out that, in addition to being legally required, accurate ingredient statements are important because FDA has received increasing numbers of reports concerning consumers who have experienced adverse reactions following exposure to allergenic substances in food. For sensitive individuals, the presence of allergens in food is potentially life threatening. Ingredients that are among the most commonly known to cause a serious allergic response are milk, eggs, fish, crustaceans, tree nuts, wheat, peanuts, soybeans and derivatives of these products.
Lastly, we have determined that your facility is subject to the registration requirement in § 415 of the Act and our implementing regulation at 21 CFR Part 1, Subpart H. During our inspection of your facility you were advised of this requirement. The failure to register a facility as required is a prohibited act under § 301 of the Act. Our records indicate that, to date, this facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
Your response to this letter should be directed to the U.S. Food and Drug Administration, Attention: Richard D. Manney, Compliance Officer at the address and telephone number listed above.
Douglas I. Ellsworth
New Jersey District