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WARNING LETTER

United King Foods Private Limited MARCS-CMS 698766 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Sheikh Muhammad Tehseen
Recipient Title
CEO
United King Foods Private Limited

Ibrahim Residency, Plot 64, Block 3 C.P & B.C.H.S, Sharfabad Karachi
Sindh-75850
Pakistan

tehseen@unitedking.com
Issuing Office:
Human Foods Program

United States

WARNING LETTER

March 7, 2025

Re# 698766

Dear Mr. Sheikh Muhammad Tehseen:

The United States (U.S.) Food and Drug Administration (FDA) conducted a Foreign Regulatory Assessment (FRRA) of your low-acid canned food (LACF) and snack food manufacturing facility, located at ST 9/ 2, 1 D/ 2, Sector 16-8 North Karachi Industrial Area, North Karachi, Sindh, Pakistan 75850 from October 21 to October 25, 2024. During that assessment, we found that you have serious violations of the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation Part 113 (21 CFR 113). At the conclusion of the assessment, the FDA investigator issued you a listing of the observation actions. After reviewing the remote regulatory assessment findings and the responses you provided, we are issuing this letter to advise you of FDA's concerns and to provide detailed information describing the findings at your facility.

As a manufacturer of LACF products intended for export to the United States, you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration, and filing of process information, and the mandatory requirements in 21 CFR Part 113. Regulations specific to the processing of LACF products are described in 21 CFR 108 and 21 CFR 113. As outlined in these regulations, a commercial processor that does not adhere to all the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 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 108.35(k), 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 108.35 and 21 CFR 113 renders your Guiab Jamu 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 LACF regulations through links in FDA's home page at www.fda.gov. FDA received your written response, describing corrective actions taken and planned by your firm, on November 12, 2024. After reviewing the inspectional findings and responses that you 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.

Emergency Permit Control regulation, (21 CFR 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113).

1. You did not provide evidence that the scheduled processes for the low-acid canned food products that you manufacture were established by a qualified person who has expert knowledge acquired through appropriate training and experience in thermal processing requirements for low-acid foods in hermetically sealed containers, as required by 21 CFR 113.83.

Specifically, your scheduled process for Gulab Jamu was not established or overseen by a qualified person having the knowledge or experience of thermal processing requirements to determine the adequacy of your "Heat Penetration and Heat Distribution Study for Gulab Jamun Retort Process" where a single probe was used to determine the coldest spot in the product and retort.

Your response states your staff has been registered for FDA approved Better Process School and that you have contacted local universities to conduct "thorough heat distribution and Heat Penetration studies that uses multiple probes to accurately identify the coldest spots in both the product and the retort." You further state that refresher training will be performed on an annual basis and the "Heat penetration & heat distribution study" will be reviewed every three years or as needed, "in collaboration with the relevant university or training institution."

We are unable to evaluate your corrective actions since you have not provided any completed training records and relevant validation or scientific studies for your manufacturing process.

2. When a process was less than the scheduled process or when critical factors were out of control you did not either fully reprocess the portion of the production involved, keeping full records of the reprocessing conditions, or set aside the portion of the product involved for further evaluation as to any potential public health significance as required by 21 CFR 113.89.

Specifically, your "(b)(4) Process" states that the product will be thermally processed at (b)(4)°C for (b)(4) at (b)(4)  bar to reach an Fo value of (b)(4) with the standard minimum Fo value listed as greater than or equal to 3. The manufacturing records reviewed during the inspection for Gulab Jamun manufactured on the dates of October 5 & 24, 2024 and May 17, 2024, revealed Fo values below the standard minimum value of (b)(4) and further did not meet and maintain the critical requirements during the (b)(4) step which includes a minimum temperature of (b)(4)°C  with a pressure of (b)(4) bar for (b)(4) minutes. For example, on May 17, 2024, the (b)(4) temperature only achieved (b)(4)°C for (b)(4) and (b)(4) seconds and never achieved (b)(4) bar; on October 05, 2024 the (b)(4) temperature never achieved (b)(4)°C or (b)(4) bar; and on October 24, 2024 the (b)(4) temperature never achieved (b)(4)°C and achieved (b)(4) bar for (b)(4) seconds.

In your response you state, you immediately adjusted your process to use FDA approved (b)(4) method to monitor critical factors in real time, hold non-conforming batches for evaluation and promised to send retention samples from the last (b)(4) batches for microbiological analysis to a third-party lab. You also state the procedure for this product was inadequately written and did not clearly mention the critical limit and that your staff was untrained.

Further, you state you will do the following: Develop and implement an SOP for identifying and handling deviations in retort processes including protocols for immediate identification of deviations from critical limits such as temperature, pressure and Fo, provide training to the operator and production supervisor conducting retort processes on how to recognize process deviations and document corrective actions, maintain records for temperature, pressure, and Fo values.

We are unable to verify the adequacy of your corrective actions because you did not provide records or other information to review, demonstrating that you have established and followed FDA approved processes, provided third party lab test results, made corrections required when a deviation occurs, or any related employee training records.

3. The initial temperature of the contents of the containers to be processed must be accurately determined and recorded with sufficient frequency to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process as required by 21 CFR 113.87(c). Specifically, the following initial temperature concerns were noted:

You did not take the initial product temperature of the coldest can being processed but instead the last can loaded into the second of two retort trolleys after leaving a steam holding tunnel. Your procedures include (b)(4) which was used to take the initial temperature. On October 5, 2024, during the processing of Gulab Jamun this probe indicated an initial product temperature, identified as (b)(4)", at (b)(4)°C. This temperature was a deviation from the minimum initial temperature of 86.6°C, as specified in the filed scheduled process. This deviation was not identified by anyone at your facility. In addition, you have never identified a process deviation and did not maintain a deviation folder.

Your response states an immediate adjustment to your procedure indicating you began measuring the initial temperature of the coldest can, not the last can loaded, to ensure compliance with the scheduled process. You also initiated a review of production management and batch sizes to prevent temperature discrepancies. Additionally, you stated you plan to do the following:

Reduce batch sizes to align with the retort trolley's capacity to prevent recurrence temperature discrepancies during product loading; revise the SOP to specify that the initial temperature measurement must be taken from the coldest can in the retort trolley including steps for identifying the coldest can in the loading process; conduct a training session for the technicians on the importance of accurate initial temperature monitoring, procedural adherence, and the critical nature of recording from the coldest can; and implement a verification system requiring supervisory staff to review initial temperature records at the start of each batch, confirming adherence to monitoring points.

We are unable to verify the adequacy of your corrective actions because you did not provide documents or other information demonstrating you are following an FDA approved scheduled process, identifying and correcting deviations when required, or employee training records.

4. You must have plant personnel involved in thermal processing systems or other critical factors of the operation under the operating supervision of a person who has attended a school approved by FDA to comply with 21 CFR 113.10.

Specifically, our inspection revealed no one at your firm has attended Better Process School or similar training and experience to adequately understand the operations and monitoring required for low acid canned food manufacturing.

In your response, you state this was not a requirement in Pakistan, but that you have added in part that you require the operator overseeing the retort operations attend FDA approved Better Process School. As a result, your Retort Operator, Quality Assurance and Production managers have been registered for this training.

We are unable to verify your corrective actions because you have not provided any training certificates or other training documentation demonstrating training has been completed.

The adequacy of your corrective actions will be verified during a future inspection. However, you did not provide any supporting evidence or an evaluation by your processing authority to address the products still on the market in the U.S. were manufactured in accordance with their scheduled process and safe for consumption. In your response to this Warning Letter, you should evaluate all lots of Gulab Jamun within shelf-life in the U.S. manufactured prior to October 25, 2024, to ensure they are commercially sterile. Please let us know if you intend to take any market action against this product.

Failure to adequately address these violations may lead to regulatory action. For instance, we may take further action to refuse admission of your imported LACF & 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). 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, examples of Import Alerts that convey information specific to foreign firms that are not in compliance with the LACF food regulations (21 CFR 108 and 113) is Import Alert #99-38, "Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control." This alert can be found on FDA's web site at: www.accessdata.fda.gov/cms_ia/ialist.html.

We also offer the following comment

Production records, including temperature-recording device records, must be signed, or initialed and dated by the reviewer. The retort continuous monitoring records you provided during the inspection for the Gulab Jamun were not signed or dated that they were reviewed by anyone at your facility to ensure the scheduled process was followed to prevent any public health concerns.

For reference, temperature-recording device records must be identified by date, retort number, and other data as necessary, so they can be correlated with the record of lots processed. Each entry on the processing and production records must be made by the retort or processing system operator, or other designated person, at the time the specific retort or processing system or condition or operation occurs, and this retort or processing system operator or other designated person must sign or initial each record form. Not later than 1 working day after the actual process, and before shipment or release for distribution, a representative of plant management who is qualified by suitable training or experience must review all processing and production records for completeness and to ensure that the product received the scheduled process.

This letter is not intended to be an all-inclusive statement of violations at your facility or in connection with your products. You are responsible for investigating and determining the cause of the 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.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 fifteen (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.

Please send your reply to the Food and Drug Administration, Attention: Victoria Palmer, Compliance Officer, Office of Compliance and Enforcement, Office of Enforcement, Division of Conventional Foods Enforcement, 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding this letter, you may contact Victoria Palmer via email at Victoria.palmer@fda.hhs.gov. Please reference Case# 698766 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Maria S. Knirk, J.D., M.B.A.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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