The company did not prepare, or have prepared, and did not implement a food safety plan, as required by regulation. Preventive Controls were not in place including Allergen Preventive Controls.
From a facility and operational standpoint, there were some major issues including:
- cheeses stored at incorrect temperatures (>59F)
- a machine used for repackaging with a cracked observation panel, a machine transfer chute made of cloth material that was not washed, and a hopper with rough seams that were discolored.
- a live bird in your warehouse which opens directly to the repackaging room where is food is exposed. In addition, bird droppings were observed on the floor throughout the warehouse between pallets of products.
From the company's website, we can see an importer who distributes international products. They also repack these items to meet retail client needs. So often we see distributors who decide to repack items without considering regulations.
FDA WARNING LETTER
International Golden Foods Inc - 619417 - 12/15/2021 | FDA
International Golden Foods Inc
MARCS-CMS 619417 — DECEMBER 15, 2021
FDA WARNING LETTER
International Golden Foods Inc - 619417 - 12/15/2021 | FDA
International Golden Foods Inc
MARCS-CMS 619417 — DECEMBER 15, 2021
Recipient:
Mr. Mansour Amiran
Owner/CEO
International Golden Foods Inc
819 Industrial Drive
Bensenville, IL 60106
United States
Issuing Office:
Office of Human and Animal Food Operations East-VI
United States
WARNING LETTER
FY22-HAFE6-WL-02
December 15, 2021
Dear Mr. Amiran:
The United States Food and Drug Administration (FDA) inspected your repackaging and storage facility, located at 819 Industrial Dr., Bensenville, IL 60106 from June 29 to July 20, 2021. Your facility repackages a variety of ready-to-eat (RTE) foods (e.g., tree nuts, seeds, and dried herbs and spices) and non-RTE foods (e.g., milled rice, rice flour, dried pasta, and wheat flour). Your facility also stores and distributes RTE soft fresh cheeses (e.g., feta cheese and goat’s milk cheese) and pre-packaged ready-to-eat food products (e.g., tahini, grilled eggplant, pickles, dates, and figs). 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 and PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA-483, Inspectional Observations, listing the deviations found at your facility.
Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control’s 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 can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.External Link Disclaimer
To date, we have not received a response to the inspectional observations listed on the Form FDA-483, dated July 20, 2021.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not prepare, or have prepared, and did not implement a food safety plan, as required by 21 CFR 117.126(a)(1). A food safety plan must include the following:
a) The written hazard analysis, as required by 21 CFR 117.130(a)(2);
b) The written preventive controls, as required by 21 CFR 117.135(b);
c) The written supply-chain program, as required by subpart G;
d) The written recall plan, as required by 21 CFR 117.139(a);
e) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR 117.145(a);
f) The written corrective action procedures, as required by 21 CFR 117.150(a)(1); and
g) The written verification procedures, as required by 21 CFR 117.165(b).
2. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility 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 environmental pathogens, such as Salmonella, to determine whether they are a hazard requiring a preventive control to comply with 21 CFR 117.130(c)(1)(ii). Your facility repackages RTE foods which are exposed to the environment prior to packaging, such as roasted pistachios, shredded coconut, sesame seeds, chia seeds, and dried herbs and spices including dill, fenugreek, and sumac. Your RTE packaged foods do not receive a treatment or otherwise include a control measure that would significantly minimize pathogens. Note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)).
b. You did not identify and evaluate undeclared allergens to determine whether they are a hazard requiring a preventive control. Your facility repackages and relabels tree nuts (e.g., pistachios and shredded coconut), as well as products that contain wheat (e.g., dried pasta and wheat flour).
c. You did not identify and evaluate allergen cross-contact to determine whether it is a hazard requiring a preventive control. Your facility repackages products with allergens (including pistachios, coconut, and wheat) on the same equipment as products without allergens. Allergen cross-contact could occur in products with different allergen profiles, without appropriate controls.
3. You did not establish and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, process, 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). Preventive controls are subject to preventive control management components 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).
Mr. Mansour Amiran
Owner/CEO
International Golden Foods Inc
819 Industrial Drive
Bensenville, IL 60106
United States
Issuing Office:
Office of Human and Animal Food Operations East-VI
United States
WARNING LETTER
FY22-HAFE6-WL-02
December 15, 2021
Dear Mr. Amiran:
The United States Food and Drug Administration (FDA) inspected your repackaging and storage facility, located at 819 Industrial Dr., Bensenville, IL 60106 from June 29 to July 20, 2021. Your facility repackages a variety of ready-to-eat (RTE) foods (e.g., tree nuts, seeds, and dried herbs and spices) and non-RTE foods (e.g., milled rice, rice flour, dried pasta, and wheat flour). Your facility also stores and distributes RTE soft fresh cheeses (e.g., feta cheese and goat’s milk cheese) and pre-packaged ready-to-eat food products (e.g., tahini, grilled eggplant, pickles, dates, and figs). 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 and PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA-483, Inspectional Observations, listing the deviations found at your facility.
Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control’s 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 can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.External Link Disclaimer
To date, we have not received a response to the inspectional observations listed on the Form FDA-483, dated July 20, 2021.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not prepare, or have prepared, and did not implement a food safety plan, as required by 21 CFR 117.126(a)(1). A food safety plan must include the following:
a) The written hazard analysis, as required by 21 CFR 117.130(a)(2);
b) The written preventive controls, as required by 21 CFR 117.135(b);
c) The written supply-chain program, as required by subpart G;
d) The written recall plan, as required by 21 CFR 117.139(a);
e) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR 117.145(a);
f) The written corrective action procedures, as required by 21 CFR 117.150(a)(1); and
g) The written verification procedures, as required by 21 CFR 117.165(b).
2. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility 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 environmental pathogens, such as Salmonella, to determine whether they are a hazard requiring a preventive control to comply with 21 CFR 117.130(c)(1)(ii). Your facility repackages RTE foods which are exposed to the environment prior to packaging, such as roasted pistachios, shredded coconut, sesame seeds, chia seeds, and dried herbs and spices including dill, fenugreek, and sumac. Your RTE packaged foods do not receive a treatment or otherwise include a control measure that would significantly minimize pathogens. Note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)).
b. You did not identify and evaluate undeclared allergens to determine whether they are a hazard requiring a preventive control. Your facility repackages and relabels tree nuts (e.g., pistachios and shredded coconut), as well as products that contain wheat (e.g., dried pasta and wheat flour).
c. You did not identify and evaluate allergen cross-contact to determine whether it is a hazard requiring a preventive control. Your facility repackages products with allergens (including pistachios, coconut, and wheat) on the same equipment as products without allergens. Allergen cross-contact could occur in products with different allergen profiles, without appropriate controls.
3. You did not establish and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, process, 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). Preventive controls are subject to preventive control management components 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).
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not hold food that can support the rapid growth of undesirable microorganisms at temperatures that will prevent the food from becoming adulterated, as required by 21 CFR 117.80(c)(4). Your facility stores soft fresh cheeses in your (b)(4) cooler. On June 29, 2021, our investigator observed approximately (b)(4) Feta (14 oz, lot 209124, Best Before Dec 2021) and a mixed pallet of (b)(4) Goat’s Milk Soft Cheese (35 oz, Best Before 10.30.2021) and (b)(4) White Cheese (35 oz, Best Before 11.30.2021) stored in the cooler at the following temperatures:
At approximately 10:45 am, the ambient temperature was measured at 59.5°F with an FDA-issued calibrated thermometer.
At approximately 2:00 pm, the ambient temperature was measured at 60.9°F with an FDA-issued calibrated thermometer.
2. You did not adequately maintain equipment, utensils, and food-contact surfaces to protect against contamination, as required by 21 CFR 117.40(a)(1) and (b). Specifically, our investigator observed a machine used for repackaging with a cracked observation panel, a machine transfer chute made of cloth material that was not washed, and a hopper with rough seams that were discolored. These surfaces are not easily cleanable and may be a source of cross-contamination with environmental pathogens such as Salmonella.
3. You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, our investigator observed a live bird in your warehouse which opens directly to the repackaging room where is food is exposed. In addition, bird droppings were observed on the floor throughout the warehouse between pallets of products. Pests must be excluded from holding and processing areas in your plant to protect against contamination of food.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify this office in writing within 15 working days of the receipt of this letter, as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Your response should be sent to the following address: U.S. Food and Drug Administration, Daniel Arrecis-Acting Compliance Officer, 550 W. Jackson Blvd., Suite 1500 Chicago, IL 60661. If you should have any questions regarding any issue in this letter, please contact Daniel Arrecis, Acting Compliance Officer, at (312) 596-4263 or email Daniel.Arrecis@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger,
Program Division Director
Office of Human and Animal Food
Operations East-VI
1. You did not hold food that can support the rapid growth of undesirable microorganisms at temperatures that will prevent the food from becoming adulterated, as required by 21 CFR 117.80(c)(4). Your facility stores soft fresh cheeses in your (b)(4) cooler. On June 29, 2021, our investigator observed approximately (b)(4) Feta (14 oz, lot 209124, Best Before Dec 2021) and a mixed pallet of (b)(4) Goat’s Milk Soft Cheese (35 oz, Best Before 10.30.2021) and (b)(4) White Cheese (35 oz, Best Before 11.30.2021) stored in the cooler at the following temperatures:
At approximately 10:45 am, the ambient temperature was measured at 59.5°F with an FDA-issued calibrated thermometer.
At approximately 2:00 pm, the ambient temperature was measured at 60.9°F with an FDA-issued calibrated thermometer.
2. You did not adequately maintain equipment, utensils, and food-contact surfaces to protect against contamination, as required by 21 CFR 117.40(a)(1) and (b). Specifically, our investigator observed a machine used for repackaging with a cracked observation panel, a machine transfer chute made of cloth material that was not washed, and a hopper with rough seams that were discolored. These surfaces are not easily cleanable and may be a source of cross-contamination with environmental pathogens such as Salmonella.
3. You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, our investigator observed a live bird in your warehouse which opens directly to the repackaging room where is food is exposed. In addition, bird droppings were observed on the floor throughout the warehouse between pallets of products. Pests must be excluded from holding and processing areas in your plant to protect against contamination of food.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify this office in writing within 15 working days of the receipt of this letter, as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Your response should be sent to the following address: U.S. Food and Drug Administration, Daniel Arrecis-Acting Compliance Officer, 550 W. Jackson Blvd., Suite 1500 Chicago, IL 60661. If you should have any questions regarding any issue in this letter, please contact Daniel Arrecis, Acting Compliance Officer, at (312) 596-4263 or email Daniel.Arrecis@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger,
Program Division Director
Office of Human and Animal Food
Operations East-VI
No comments:
Post a Comment