- K.I.Z. FOODS LIMITED
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
Nov 12 2014
VIA EXPRESS DELIVERY
Mr. Altaf Badami
KIZ Foods Limited
Survey No. 199, Muhuva Savarkundla Road
Taveda, Taluka: Mahuva-364 290
Reference No. 441450
Dear Mr. Badami:
The U.S. Food and Drug Administration (FDA) inspected your acidified foods facility located atSurvey No. 199, Muhuva Savarkundla Road, Taveda, Taluka: Mahuva-364 290 Bhavnagar, India, on May 15 and 16, 2014. During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)), the Acidified Foods regulation (21 CFR 114), and the current Good Manufacturing Practices regulation (21 CFR 110). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at your firm. As of this date, you have not responded to the FDA-483.
As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act) and all applicable federal regulations. Regulations specific to the processing of acidified food products are described in 21 CFR 108 and 21 CFR 114. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified food products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. You can find the Act and the Acidified Foods regulations through links in FDA’s home page at www.fda.gov
Your significant violations are as follows:
1. As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels; and source and date of the establishment of the process; for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, you failed to file a scheduled process with FDA for your shelf stable acidified garlic paste, ginger paste, and ginger garlic paste packaged in 720g (25.40 oz.) glass jars. These processes must be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods as required by 21 CFR 114.83.
2. Your firm failed to have personnel involved in acidification, pH control, heat treatment, and critical factors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner as required by 21 CFR 108.25(f). Specifically, you manufacture and export shelf stable acidified garlic paste, ginger paste, and garlic ginger paste packaged in 720g (25.40 oz.) glass jars that are exported to the United States and no one at your firm has attended or completed a Better Process Control School.
3. Your firm failed to exercise sufficient control including frequent testing so that the finished equilibrium pH values are not higher than 4.6 as required by 21 CFR 114.80(a)(2). Specifically, your firm does not conduct any pH testing of products. Your firm has an “Acceptance Criteria” of pH < 3.5="" for="" acidified="" products;="" however,="" you="" do="" not="" monitor="" and="" record="" the="" finished="" equilibrium="" ph="" of="" your="" acidified="" food="">
4. Your firm failed to test and examine containers to ensure that the containers suitably protect the food from leakage and contamination as required by 21 CFR 114.80(a)(4). Specifically, you do not conduct container closure exams of any of your shelf stable acidified food products including garlic paste, ginger paste, and garlic ginger paste packaged in 720 g (25.40 oz) glass jars that are exported to the United States.
5. Your firm failed to mark each container with an identifying code specifying the establishment where the product was packed and the product contained therein as required by 21 CFR 114.80(b).
6. Your firm failed to maintain equipment, containers and utensils that are used to hold food in a manner that will protect them against contamination as required by 21 CFR 110.80(b)(7). Specifically, on 5/15/14, the FDA investigator observed the ribbon blender located in the garlic mixing room, which is used to mix the garlic paste, ginger paste, and garlic ginger paste, to have cracks and broken soldered welds on the ends of the metal support pipes with a heavy accumulation of a wet black substance inside the cracks and metal rods. These rods where the cracks and wet black substance were observed are in direct contact with the product during blending and mixing.
7. Your firm failed to clean food contact surfaces and utensils as frequently as necessary to protect against the contamination of food as is required by 21 CFR 110.35(d). Specifically, as a general practice you use untreated well water at ambient temperature to clean all the equipment in your facility, including food contact surfaces such as stainless steel sorting tables, blenders and mixers, hoppers, and finished product packaging dispensers; and non-food contact surfaces. You do not use any hot water, soap, detergent, or sanitizer for cleaning inside the facility. Additionally, the garlic sorting conveyor line was observed to have a buildup of food residue inside the white mesh plastic conveyor line after it was cleaned.
8. Your firm failed to have hand washing facilities with heated running water as is required by 21 CFR 110.37(e). Specifically, on 5/15/14, the only hand washing sink for your processing facility, which is located near the employee entrance, did not have warm or hot running water.
9. Your firm failed to take effective measures to exclude pests from the processing area as is required by 21 CFR 110.35(c). Specifically, on 5/15/14, the FDA investigator observed the following:
a. Two live birds perched directly above an opened vent in the male employee locker room. The open vent leads directly outside. Additionally, bird droppings were observed on the floor of the locker room directly below the opened vent.
b. One live bird flying around the finished product packaging room directly above opened and exposed product in the process of being packaged.
c. A gap of approximately 1” below the overhead door in the finished product room
d. No less than 5 live flies flying in the garlic sorting room and landing on the plastic food contact conveyor which had an accumulation of food residue.
e. No less than 5 live flies flying throughout the garlic mixing room.
10. Your plant is not constructed in such a manner to allow floors to be adequately cleaned and sanitized and maintained in good repair as is required by 21 CFR 110.20(b)(4). Specifically, on 5/15/14, the FDA investigator observed various areas in the production facility to have cracked and broken tiled floors with standing water and residue as follows:
a. Cracked and broken tile with residue buildup on the floor at the entrance of the garlic sorting/pulverizing room into the processing facility.
b. Cracked and broken tiles on the floor with standing water and residue in the area in front of the garlic washer in the garlic sorting/pulverizing room. The broken floor tile was observed to push water out from underneath it as it was stepped on.
c. Cracked floor tiles throughout the garlic blending room, leaving water and residue around the floor drain in the corner of the room, at the entrance of the room and in the middle of the production room and below the ribbon mixer (a blender where the garlic paste products are mixed). Additionally, the accumulation of a wet black sludge-like substance was observed in the standing water below the ribbon mixer.
d. Cracked and broken tiles with standing water and residue below the kettle mixer where ginger paste is cooked and mixed.
11. Your firm failed to have suitable hand drying devices or sanitary towels as required by 21 CFR 110.37(e)(3). Specifically, on 5/15/14, your hot air hand dryer located at the employee entrance into the processing facility that is used to dry employees’ hands after they are washed was not in service and displayed a sign that read “Under Maintenance.” There were no paper towels or other hand drying devices available.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. 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 do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported acidified food 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 Acidified Foods regulations (21 CFR 108 and 114) is Import Alert #99-38. This alert can be found on FDA’s web site at: www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Acidified Foods regulations (21 CFR 108 and 114), and the current Good Manufacturing Practices regulation (21 CFR 110). 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 reinspection-related costs. A reinspection 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 reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Leonora Katherine Darlington, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Leonora.Darlington@fda.hhs.gov
. Please reference # 441450 on any submissions and within the subject line of any emails to us. You may also contact Leonora Katherine Darlington via email if you have any questions about this letter.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition