WARNING LETTER

Pt Dua Kelinci MARCS-CMS 670439 — February 09, 2024

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

Recipient:: Recipient Name

Hadi Sutisno; Recipient Title

President/Director; Pt Dua Kelinci; Jalan Raya Pati Kudus Km 6.3 Pati Kudus
Pati, Jawa Tengah
59163
Indonesia

Issuing Office:: Center for Food Safety and Applied Nutrition; United States

February 9, 2024

WL 670439

Dear Mr. Sutisno:

The United States Food and Drug Administration (FDA) inspected your ready-to eat (RTE) confectionaries and snack foods manufacturing facility, located at Jalan Raya Pati Kudus Km 6.3 Pati Kudus, Pati, Jawa Tengah, Indonesia 59163 from August 22 through August 23, 2023. During the inspection, the FDA investigator 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). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your firm.

Based on FDA’s inspectional findings, we have determined that the RTE food 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.

FDA received your written response, describing corrective actions taken and planned by your firm on September 13, 2023. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your response below.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

1. You did not maintain your plant in a clean and sanitary condition, and you did not clean and sanitize your utensils or equipment in a manner that protects against contamination, as required by 21 CFR 117.35(a). Specifically:

a. In your coated peanut factory, you clean utensils, buckets, trays, and bowls used in the production of non-oily products by washing them in a large plastic bin with visibly dirty water or rinsing them with cold water and without using sanitizer. According to your System Regulatory and Laboratory Manager (“manager”), you clean equipment and utensils used in the production of oily products with a multipurpose cleaner for (b)(4) minutes, repeat, and then place in a bin with water without sanitizer. You do not have sinks for washing utensils in this factory. On August 22, 2023, our investigator observed an employee washing two rags in a puddle on the floor in the cleaning room. The employee then used the rags to wipe down buckets identified as clean.
b. A sanitation room in your wafer factory is partially exposed to the outside. The sanitation room has a row of sprayers/hoses and a drainage ditch along the wall leading outside to a pipe going to the wastewater facility. Our investigator observed large dirty plastic bins, some of which contained apparent dirty water and some of which contained buckets/containers being soaked. According to your manager, you clean oily/greasy containers by placing them in one of the large bins with a multipurpose cleaner for (b)(4) minutes, repeat, and then place in a bin with water without sanitizer. You clean containers previously containing dry or nonoily food by hosing off with cold water. Then you wipe all the containers/bins/ implements with a rag. The investigator observed employees wiping these items with dirty rags. Furthermore, your manager identified a bucket used to transport dough from the dough machine to the wafer machine as clean, but our investigator observed the (b)(4) of the bucket was visibly soiled.

Your response includes photographs of cleaned buckets, lids, and utensils used in production but does not address the insanitary use of dirty rags observed during the inspection. Also, your revised sanitation procedures do not include the use of sanitizer.

2. You did not clean your utensils and food contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against allergen cross-contact and contamination of food, as required by 21 CFR 117.35(d).

You manufacture various coated peanut and wafer products containing different allergens including soy, milk, wheat, peanuts, tree nuts, eggs, and sesame. You do not use dedicated lines to produce products containing different allergens in either the peanut or wafer factories or rotate production in any way to adequately avoid allergen cross-contact. Further, your manager stated that you do not clean between products containing different allergens; you only clean equipment at the end of every shift. Additionally, utensils, buckets, trays, and bowls used in production are either washed in large plastic bins with visible debris or simply hosed off with water, as described above. In addition, our investigator observed the following:

a. An employee used a metal spatula to stir peanuts in peanut coating and then laid the spatula on top of a visibly dirty coating machine. The employee reused the spatula to stir the peanuts and coating mixture without washing or sanitizing the spatula.
b. Fried coated peanuts were transferred to bags with a dirty (b)(4) lined with an open (b)(4) plastic bag prior to packaging. You stated that a new interior plastic is used but our investigator observed the (b)(4) bag to be ripped and not closed properly, allowing the coated peanuts to touch the (b)(4) bag.
c. Ingredients in the prep area of the wafer factory were staged in plastic bins which were visibly dirty on the inside.
d. An employee transferred wafer dough to the wafer machine in visibly dirty buckets.
e. An employee transferred wafers to the packing machine in visibly dirty bins.

Your response indicates that you revised your allergen control procedure to include “(b)(4),” which addresses finished product labeling, sequencing allergen production, and ensuring that finished product bears the correct allergen information. The procedure also states that if there is a sequence mismatch, additional cleaning will be performed. Your response includes documentation that you cleaned and made changes to your sanitation procedures for utensils but does not address some of the observations made while you were manufacturing coated peanuts and wafer, including the insanitary use of the metal spatula, and holding and transferring product in visibly dirty bins.

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, our investigator observed the following:

a. The wafer machine used to flatten the dough was dirty with visible food debris on the equipment directly above the in-process wafers.
b. The mixers used to prepare the ingredients for making the peanut coating were dirty with visible food debris on the equipment above the product.
c. The non-food-contact surfaces of the peanut coating machine and coated peanut fryer had significant residue buildup which appeared to have been present for more than 1 day. The non-food contact surfaces were adjacent and above in-process and finished product.

Your response includes photographs of cleaned mixers and the addition of stainless steel to some of the manufacturing equipment used in production. However, your response does not address the other instances of built-up residue on the equipment or identify any changes to the cleaning of the manufacturing equipment.

4. Your equipment and utensils were not designed and of such material and workmanship as to be adequately cleanable and were not adequately maintained to protect against contamination, as required by 21 CFR 117.40(a). Specifically, on August 22, 2023, our investigator observed the following:

a. The (b)(4) of one of the mixers used in the coated peanut factory had visible rust.
b. The metal mixer paddles had cracks. Your manager stated that the mixers are only cleaned with water and a metal spatula.
c. The metal spatula used to scrape the mixer in the coated peanut factory was not smooth and had visible uneven welds.
d. The inside of the (b)(4) feeding coated peanuts into the peanut fryer had uneven and broken welds with visible buildup.

Your response includes photographs of the cleaned mixers but does not provide any information regarding the condition of the (b)(4) of the mixer or the paddles. Also, your new sanitation procedure includes photographs of cleaned spatulas, but you have not indicated whether the metal spatula used to clean the mixer has been replaced.

Failure to adequately address these violations may lead to regulatory action. For instance, we may take further action to refuse admission of your imported snack food products under section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). For your information, an example of an Import Alert that conveys information specific to foreign firms where FDA has evidence that a firm's lack of or inadequate preventive controls or inadequate CGMPs has led to adulteration of food products within the meaning of section 402(a)(4) of the Act is Import Alert #99-43. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.

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 that your firm 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.

In addition to the violations described above, we offer the following comments:

The sanitation videos provided with your response demonstrate your use of high-pressure hoses to spray down utensils and the floor during cleaning. The use of high-pressure hoses may contribute to the spread of any pathogens in your facility, if present. It appears that you only conduct environmental monitoring monthly (approximately (b)(4) swabs per division/ factory and tests for Total Plate Count (TPC), E. Coli and Coliform bacteria). Environmental monitoring should be conducted to look for environmental pathogens such as Listeria monocytogenes and Salmonella. Your procedures may be contributing to the spread of pathogens, but you do not have information to determine the presence of environmental pathogens in your facility at this time.

Based upon information available to the Agency, your facility appears to be subject to the preventive control requirements (primarily located in subparts C and G) of the CGMP & PC rule, 21 CFR Part 117. Under those requirements, a covered food facility must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control (e.g., allergens, mycotoxins, and recontamination with environmental pathogens) will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 USC §§ 342 and 343(w)).

Furthermore, your food products are RTE foods exposed to the environment prior to packaging which do not receive a lethal treatment after packaging. Therefore, you should also evaluate environmental pathogens, such as Salmonella and Listeria monocytogenes, as potential hazards requiring a sanitation preventive control. Please note that environmental monitoring is required when contamination of a RTE food with an environmental pathogen is a hazard requiring a preventive control, as required by 21 CFR 117.165(a)(3).

Note that the 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)].

We will verify the adequacy and ongoing implementation of your corrective actions during a future inspection.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response to this letter should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. 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 your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.

You should direct your written reply to Victoria Wagoner, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-607), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Wagoner via email at Victoria.Wagoner@fda.hhs.gov. Please reference #670439 on any submissions and on the subject line of any emails to us.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director, Office of Compliance
Center for Food Safety and Applied Nutrition