September 18, 2012

 

Our Reference #  3003340486

 

Fatai Yusufu, President/CEO

Fayus, Inc. dba Yusol International Foods

6200 88th Street

Sacramento, CA 95828

 

Dear Mr. Yusufu:

 

Between June 1, 2012 and June 13, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your food repacking warehouse located at 6200 88th Street, Sacramento, CA 95828. During the inspection, the FDA investigator documented significant violations of the current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110) and collected samples from your facility. Based on our findings, the foods stored and processed at 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. In addition, your Ground Cassava (aka “Yellow Gari”) is adulterated within the meaning of section 402(a)(3) of the Act [21 CFR § 342(a)(3)] in that it consists in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food. You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.

 

The food products stored in rodent and insect susceptible packaging and processed at your facility are adulterated within the meaning of section 402(a)(4) of the Act  [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, and held under insanitary conditions whereby they may have become contaminated with filth.  During our inspection, FDA collected a filth sample comprised of 11 subsamples from various areas of your facility. The 11 subsamples were analyzed and revealed evidence of rodent infestation and filth.  The evidence included rat/mouse excreta pellets, dead adult moths, bundles of rat/mouse hairs, dead adult silverfish (alive at the time of sample collection), nesting material, and dead adult beetles throughout your repacking warehouse facility. We acknowledge that on June 7, 2012, your firm took prompt action to clean rat/mouse excreta pellets and other filth from the warehouse.

 

Your Ground Cassava product is further adulterated within the meaning of section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)], because it consists in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food.  FDA collected a sample comprised of 6 subsamples (excluding the 2 subsamples as controls) from a pallet of Ground Cassava in the middle of your facility during our inspection. FDA analyzed the six subsamples for filth. Our analysis found evidence of rodent activity and filth directly in contact with food.  The evidence included rat/mouse excreta pellets, product testing positive for xanthydrol and fluorescent stained areas showing positive urea, rat/mouse gnaw marks on plastic bag, and rat/mouse hairs on plastic cutting material in your Ground Cassava.  We acknowledge that on June 7, 2012, your firm took prompt action to recondition or destroy portions of the affected Ground Cassava product.

 

The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with the Act and FDA regulations. You should take prompt action to ensure that your food products are not manufactured under conditions which may cause them to be contaminated with filth or rendered injurious to health.  Failure to promptly correct violations of the Act may result in regulatory action without further notice, such as seizure and/or injunction.

 

Also, our investigator documented serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110), and discussed observations on the form FDA-483, Inspectional Observations, when it was issued to you on June 13, 2012. On July 17, 2012, a joint FDA/California FDB conference call was held to discuss the FDA inspectional findings and analytical results. During the conference call, you informed FDA of the corrective actions your firm has taken to address the deficiencies noted on the Form 483. We acknowledge and appreciate your efforts to clean and repair your facility as a result of our inspection, and we acknowledge that you have hired a food quality consultant and pest control company to assist your firm in achieving compliance. We also acknowledge your actions in reconditioning and destroying some of the Ground Cassava product described in the aforementioned paragraph once you were notified of their suspected contamination by our investigator. However, you did not provide specific documentation of the procedures used in your reconditioning process in order for us to undertake an informed evaluation of your corrective actions.  

 

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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 re-inspection-related costs.

 

Please respond in writing within fifteen (15) days from your receipt of this letter.  Your response should include the current status of your corrective actions and the specific steps you have taken to correct the noted violations.  In your response, include documentation such as the current status of the remaining Ground Cassava, certification of actions performed by a licensed exterminator, other actions performed to control and prevent further entry of pests, steps on how you plan to protect food products from possible contamination, and/or any other useful information that would assist us in evaluating your corrections and to prevent the recurrence of similar violations.  If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining deviations.

 

Please send your reply to the Food and Drug Administration, Attention: Lawton Lum, Director of Compliance Branch, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502.  If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.

 

Sincerely,

/S/ 

Barbara J. Cassens

District Director

San Francisco District