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WARNING LETTER

Iacofano's Group LLC MARCS-CMS 606657 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
John L. Iacofano
Recipient Title
Owner
Iacofano's Group LLC

1749 Sam Rittenberg Blvd.
Charleston, SC 29407
United States

Issuing Office:
Division of Human and Animal Food Operations East III

United States


May 28, 2020

WARNING LETTER
(CMS# 606657)


Dear Mr. Iacofano:

The U.S. Food and Drug Administration (FDA) inspected your Ready-to-Eat (RTE) food manufacturing facility located at 1749 Sam Rittenberg Blvd in Charleston, South Carolina from January 7, 2020, through January 22, 2020. During our 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 determined that the food manufactured in your facility is 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 it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been 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 further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.

At the conclusion of the inspection, FDA issued an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. To date we have not received a response from you describing the corrective actions you plan to take to correct the identified deficiencies.

We found the following significant violations:

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

The CGMP & PC rule requires you to prepare, or have prepared, and implement a food safety plan, which must include the following:
(1) The written hazard analysis, as required by § 117.130(a)(2);
(2) The written preventive controls, as required by § 117.135(b);
(3) The written supply-chain program, as required by subpart G;
(4) The written recall plan, as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);
(6) The written corrective action procedures, as required by § 117.150(a)(1); and
(7) The written verification procedures, as required by § 117.165(b).

When FDA requested your food safety plan during the inspection, you provided documents titled “Iacofano's Catering & Foodservice Standard Operating Procedure” and “HACCP-based SOPs.” As explained below, these documents collectively contain some but not all required elements of a food safety plan.

1. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility, including your ready-to-eat (RTE) brownies, macadamia nut cookies, and grape products to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,

a. You did not identify and evaluate food allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your facility manufactures various products with different allergen profiles on the same day and on shared equipment, such as cutting boards and knives, which can result in allergen cross-contact without appropriate controls.
b. You did not identify and evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, as a known or reasonably foreseeable hazard to determine whether environmental pathogens are a hazard requiring a preventive control. Your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or downstream customer) that would significantly minimize the pathogen.

2. 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 or misbranded under section 403(w) of the Act, as required by 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)). You have established some preventive controls, e.g., your “HACCP-based SOPs” include process controls in your procedures for “Cooking Potentially Hazardous Foods” and “Cooling Potentially Hazardous Foods.” However, your firm lacks other preventive controls such as food allergen controls. Your manager provided your “HACCP-Based SOP” titled “Preventing Cross-Contamination During Storage and Preparation” as your allergen control program; however the document does not mention allergens or include all the procedures, practices, and processes to protect food from allergen cross-contact and ensure that the finished food is not misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(c)(2).

3. You did not document the monitoring of preventive controls, as required by 21 CFR 117.145(b). When monitoring records were requested on January 8, 2020, you were only able to provide blank records.

4. You manufacture RTE food that is exposed to the environment at numerous stages of manufacturing and does not receive a subsequent control to significantly minimize or prevent environmental pathogens. You have identified sanitation control procedures (e.g., Equipment Cleaning and Sanitizing) in your “Standard Operating Procedures,” and you have an Environmental Monitoring Program. However, you did not implement your environmental monitoring procedures, as required by 21 CFR 117.165(b)(3). Specifically, your environmental monitoring program (which does not appear to be specific for your facility, i.e., page 2 refers to “(b)(4) Foods”) states that you will conduct environmental swabbing for Listeria spp., Salmonella, and total coliform/E. coli at specific frequencies depending on the location. The frequencies are as follows: (b)(4). However, you stated during the inspection that only (b)(4) locations are (b)(4). Further, your most recent analytical results, dated July 17, 2019, only show results for Listeria.

Current Good Manufacturing Practices (Subpart B)

1. You did not take reasonable measures and precautions to ensure persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR §117.10(b). Specifically,

a. On January 7 and 8, 2020, multiple employees were observed wearing gloves and handling insanitary objects before returning to handling food, food contact surfaces, and processing utensils without changing gloves. On January 8, 2020, an employee was observed handling food with torn gloves.
b. On January 7, 2020, an employee was observed handling Macadamia Nut Cookies, which contain the major food allergens wheat, soy, milk, tree nuts, and egg, and then without changing their gloves handling bread for another product which was only labeled as containing wheat and soy.

2. You did not maintain your plant in a clean and sanitary condition or keep your plant in repair adequate to prevent food from becoming adulterated, as required by 21 CFR §117.35(a). Specifically, on January 8 and 8, 2020:

a. The ceiling in the kitchen and the food preparation rooms were observed to be rusty, sagging, discolored, and in disrepair. This condition was also observed during previous FDA inspections in 2017 and 2018.
b. A ceiling vent in front of the preparation room freezer was observed to be covered in filth.
c. Floor tiles were observed to be loose in multiple locations in the packing room and kitchen, preventing adequate cleaning. This condition was also observed during previous FDA inspections in 2017 and 2018.
d. The floor threshold in front of kitchen freezer (b)(4) was observed to be deeply pitted with exposed wood, which is a surface that is not easily cleanable. This condition was also observed during previous FDA inspections in 2017 and 2018.
e. A residue was observed on shelves used to hold clean utensils.
f. The drain tubes for the freezers in the facility were observed to have built up frozen condensate on them, and in preparation room freezer (b)(4) a cooler on the freezer floor was encased in frozen condensate.

3. You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically, on January 7 and 8, 2020, our investigators observed:

a. Multiple shelves directly over food preparation areas had dust build up and debris.
b. Multiple utensil storage racks contained a residue build up on surfaces where cleaned utensils were stored.

4. Each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties, as required by 21 CFR § 117.4(b)(2). You did not establish and maintain documentation of this training as required by 21 CFR § 117.4(d). During the inspection, your Manager stated that employees undergo on-the-job training as well as Employee Health Training and Employee Food Safety Training; however, your firm was unable to provide any completed training records to demonstrate the employees had received any training. This is a repeat observation from the previous FDA inspections in 2017 and 2018.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable requirements. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-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. Reinspection-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 reinspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.

Please respond within fifteen (15) working days of the receipt of this letter with the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. You should include documentation in your response, including photographs, food safety plans(s), procedures, or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Please send your reply to the Food and Drug Administration, Atlanta District Office, to the attention of Mr. Derek Price, Director Compliance Branch. If you have any questions about this letter, you can contact Mr. Price via telephone at (404) 253-2277.

Sincerely,
/S/

Ingrid A. Zambrana
District Director- FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations- East Division 3

 

Cc: Mr. Derek Underwood
Assistant Commissioner for Agriculture
South Carolina Department of Agriculture
123 Ballard Ct.
West Columbia, SC 29172
 

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