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WARNING LETTER
June 29, 2011
Our Reference: 3000207231
Peter T. Kam, Managing Partner
First Commercial Kitchen, L.L.C.
94-491 Ukee St. # B
Waipahu, HI 96797-4212
Dear Mr. Kam:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing facility located at 94-491 Ukee St. # B, Waipahu, Hawaii between the following dates: December 28, 2010 and February 4, 2011. The inspection determined that your facility produced acidified foods and revealed that you have significant deviations from the requirements of the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114).
These significant deviations caused your acidified food products to be adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342 (a)(4)] in that they have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. The Act and regulations can be found on FDA’s webpage at www.FDA.gov.
As an acidified food processor, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act), and regulations relating to the processing of acidified foods and current good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor fails to fulfill the mandatory requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements within 21 CFR Part 114.
The investigators discussed with you observations noted on the Form FDA-483, Inspectional Observations, which was issued to you on February 4, 2011. We noted the following serious violations:
1. Your firm must process each food in conformity with at least the scheduled process filed with FDA, as required by 21 CFR 108.25(c)(3)(i). Specifically, your firm has filed with FDA the scheduled process for your Black Bean Sauce product in 12 fl. oz glass bottles under SID: (b)(4) under FCE (b)(4). According to your scheduled process, the maximum equilibrium pH for this product is (b)(4). However, FDA laboratory analysis of this product tested the equilibrium pH of this product to be as high as 4.8.
2. 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, our inspection found that your firm failed to file a scheduled process with FDA for at least two acidified food products you manufacture, specifically Arturo’s Hot Flavors of Hawaii Moloka’i Hot Sauce and India Café Creamy Tikka Masala Sauce.
3. Your firm must exercise sufficient control including frequent testing and recording of results so that the finished equilibrium pH values are not higher than 4.6, as required by 21 CFR 114.80(a)(2). However, our investigators determined that your firm is not monitoring the final equilibrium pH for any of your processed acidified food products, including Arturo’s Hot Flavors of Hawaii Moloka’i Hot Sauce, India Café Creamy Tikka Masala Sauce, and Barb’s Local Style and Ohana Flavors Black Bean Sauces. Without frequent testing of results, you cannot ensure that the finished equilibrium pH values of your products are not higher than 4.6.
4. Your firm must maintain processing and production records showing adherence to the scheduled processes, including records of pH measurement and critical factors intended to ensure a safe product, as required by 21 CFR 114.100(b). However, your firm has filed with FDA the scheduled process for your Black Bean Sauce product in 12 fl. oz glass bottles under SID: (b)(4) under FCE (b)(4) with the following parameters: maximum equilibrium pH of (b)(4), process time (b)(4) and process temperature of (b)(4). Our investigators determined that you did not document and maintain on your batch records that the target equilibrium pH and critical factors including minimum process time and temperature were met.
5. Your firm must 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 FDA commissioner as required by 21 CFR 108.25(f). However, no one at your firm has attended such a school.
6. Your firm must ensure that each container is marked with an identifying code specifying the establishment where the product was packed, the product contained therein, and the year, date, and period during which it was packed, as required by 21 CFR 114.80(b). However, our investigators observed that containers of India Café Creamy Tikka Masala Sauce were not marked with an identifying code, and that containers of Barb’s Local Style Black Bean Sauce and Arturo’s Hot Flavors of Hawaii Moloka’i Hot Sauce were not marked with a code specifying the establishment where the products were packed and the products contained therein.
Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/
Further, violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110), including poor employee practices, were identified by our investigators and documented on the Form FDA-483, Inspectional Observations, issued to your firm. Prior to the conclusion of the inspection, we observed that you initiated corrections by posting of instruction signs for employees to follow. The adequacy of your corrections will be verified during our next inspection.
We acknowledge that based on FDA’s findings and inspection by the Hawaii State Department of Health (DOH), the DOH had issued your firm a Notice of Permit Suspension and Order to Cease and Desist on January 24, 2011, which restricts your firm from processing food products. We also acknowledge that on January 19, 2011, during FDA’s inspection, a joint voluntary recall had been conducted on your Black Bean Sauce product on behalf of your firm based on the FDA sample results being higher than 4.6. Furthermore, on January 25, 2011, the DOH issued a recall of more than a hundred products that your firm manufactured. A revised list of recalled products was issued on January 27, 2011.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility or with respect to your products. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Acidified Foods regulations (21 CFR 114) and the Current Good Manufacturing Practice regulations (21 CFR Part 110).
You should take prompt action to correct the violations described in this letter and to establish and implement procedures which will prevent them from occurring in the future. Failure to implement lasting corrective action on violations may result in regulatory action by FDA without further notice. The Act authorizes actions such as injunctions against manufacturers and distributors of illegal products, the seizure of such products, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the current status of your corrective actions and the specific steps that you have taken to correct the noted violations. You should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state the time within which you will complete the remaining corrections.
Please send your reply to the attention:
Darlene Almogela
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issue in this letter, please contact Ms. Almogela at 510-337-6769 or Juliane Jung-Lau, Compliance Officer at 510-337-6793.
Sincerely,
/s/
Barbara J. Cassens
San Francisco District Director
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