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- Food & Beverages
Recipient NameMr. Robert Calabro
- Porfirios Italian Foods, Inc.
320 Anderson Street
Trenton, NJ 08611
- Issuing Office:
- Division of Human and Animal Food Operations East II
June 21, 2023
Dear Mr. Calabro:
The United States Food and Drug Administration (FDA) inspected your pasta manufacturing facility, located at 320 Anderson Street, Trenton, NJ on January 13 and 17, 2023 and March 17, 2023. During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on FDA’s inspectional findings, we have determined that the pasta products manufactured in your facility are 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)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided a response to the inspection on March 29, 2023, describing corrective actions taken by your firm. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must also include the following:
1) The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2) The written preventive controls, as required by 21 CFR § 117.135(b);
3) The written supply-chain program, as required by Subpart G;
4) The written recall plan, as required by 21 CFR § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6) The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7) The written verification procedures, as required by 21 CFR § 117.165(b).
However, you did not have a food safety plan with any of the required elements. For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). Specifically:
a) You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your facility manufactures pasta products containing allergens such as wheat, milk, and egg. (Your facility also manufactures a seafood pasta product – ravioli containing the lobster allergen). Additionally, you use shared equipment (i.e., (b)(4) and (b)(4) filler, and pasta sheeter) and utensils to manufacture pasta products containing different allergen profiles. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR § 117.135(c)(2)).
You do not have appropriate controls in place for the allergen cross-contact hazard. Your sanitation of the (b)(4) mixer and (b)(4) filler consists of scraping manually, blowing with compressed air, and wiping with a bleach sanitizing solution. This sanitation practice does not include cleaning with detergent between pasta products containing different allergenic ingredients. For example, you manufacture cheese ravioli (which does not contain seafood such as lobster) on the same (b)(4) and (b)(4) filler used to manufacture lobster ravioli without cleaning with detergent between products.
b) You did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Metal screening in the bottom of your wooden-framed sifters was observed to have broken and was missing metal pieces. You do not have metal detectors and are not implementing any other programs, such as visual inspection, to control the metal hazard.
c) You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures pasta products containing wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON).
A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410). You do not have this program in place.
In your response dated March 29, 2023, you stated that “to establish and maintain a written food safety plan all production will follow a schedule, enforced by a manager on site.” You indicated that you intend to implement sanitation and allergen controls to prevent allergen cross-contamination in conjunction with this schedule. You also indicate that you plan to start (b)(4) to ensure the control of cross-contact between products with different allergen profiles and that all your production using seafood will be scheduled on a designated day. Further, managers will follow a written preventive control program to monitor and verify these procedures and you will require a manager to become a PCQI and take the appropriate training course. Additionally, you stated that when processing foods that require a preventive control for foreseeable hazards, your firm is assigning lot numbers which will be used for any potential recall. You also stated that you requested certificates of analysis (COA) for all cheese and flour supplies. However, your response did not include a written food safety plan including a hazard analysis to identify hazards requiring a preventive control. You also did not provide any written procedures for sanitation, metal fragments, or supplier approval.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Compliance Officer Melissa B. Libby at U.S. Food & Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Melissa Libby by telephone at (973) 331-4997 or by email at firstname.lastname@example.org.
Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration