|Company:||YeYa Products Corp|
|Subject:||CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated|
|Issuer:||Florida District Office|
|Issued:||Nov. 17, 2010||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
RETURN RECEIPT REQUESTED
November 17, 2010
Mr. Roberto D. Sanchez
YeYa Products Corp.
3820 NW 32nd Avenue
Miami, FL 33142
Dear Mr. Sanchez:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 3820 NW 32nd Avenue, Miami, FL 33142, from July 22, 2010, to July 26, 2010. The inspection revealed serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP). At the close of the inspection, you were issued a form FDA 483, List of Inspectional Observations, which included a number of insanitary conditions observed in your manufacturing facility. These conditions cause your products, YeYa Plain, Butter and Garlic crackers, to be adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act) in that they had been prepared under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. You can find the Act through links on the FDA's homepage http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm .
The inspection revealed the following violations:
1. Your firm failed to maintain its equipment, containers, and utensils, used to convey, hold, or store raw materials, work-in-process, or food in a manner that protects against contamination during manufacturing or storage, as required by 21 CFR 110.80(b)(7).Specifically, our investigator observed:
• The ceiling of the proofers, where the cracker dough is placed to rise, had a moldlike substance on it. The raw crackers could become contaminated from the drops of steam, which form on the moldy ceiling.
• Uncovered barrels of cracker dough stored in the cooler were exposed to mold, which was growing on the wall above the door and on the ceiling.
2. Your firm failed to store raw materials in a manner that protects against contamination and minimizes deterioration, as required by 21 CFR 110.80(a)(1). Specifically, our investigator observed:
• Stored in the cooler were six (6) buckets of uncovered dough.
• Wooden tops that had accumulated dirt and organic material covered eight (8) buckets of dough in the cooler.
3. Your firm failed to clean and sanitize your equipment to protect against contamination of food or food-contact surfaces, as required by 21 CFR 110.35(a). Specifically, our investigator observed:
• Your cleaning process for the mixers includes a step where undiluted bleach is poured in the mixer and wiped around inside with a cloth. Undiluted bleach cannot be used as a sanitizing agent because it is toxic and there is a risk that food which comes into contact with surfaces cleaned with undiluted bleach will be contaminated.
4. Your firm failed to design, construct, and use its equipment and utensils to preclude the adulteration of food with contaminants, as required by 21 CFR 110.40(a). Specifically, our investigator observed the following:
• A wooden box, made from splintered wood, collected dough scraps at the end of the depositor conveyor. These dough scraps were recycled back into the roller and were used to shape additional crackers.
• The conveyor belt, which transports dough and ready-to-eat crackers, was made of frayed cloth and was held together in some places with ties, leaving gaps in between sections of the belt.
5. Your firm's facility was not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair to prevent condensate from fixtures or pipes from contaminating food, food-contact surfaces, or food packaging materials, as required by 21 CFR 110.20(b)(4). Specifically, our investigator observed the following:
• The walls and ceiling of the proofer room are constructed of material that is not smooth and contains uneven surfaces. Such material cannot be adequately cleaned and kept clean and in good repair because the grooves of the uneven surfaces collect dirt, dust, and other contaminants.
• The floor has many holes and depressions where standing water and dirt collect For example, steam, which condensed and mixed with dirt on the floor, formed a muddy puddle in front of stowed carts with trays of in-process crackers. The puddle's proximity to the lower trays of these carts risks these crackers could become contaminated. Additionally, the wheels of these carts routinely pass through this puddle, tracking muddy water throughout the processing area.
6. Your firm failed to maintain your building and fixtures of the plant in a sanitary condition, as required by 21 CFR 110.35(a). Specifically, our investigator observed:
• A mold-like substance was on the ceiling of the proofer.
This letter is not intended to be an all-inclusive list of the violations at your facility. You are responsible for ensuring that your processing facility operates in compliance with the Act and the CGMP regulation for foods (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not correct these violations. Failure to implement corrective action may result in regulatory action being initiated by FDA without further notice. Such action may include seizing your products and/or enjoining your firm from operating.
We request that you notify this office in writing within fifteen (15) working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. Your response should include documentation on how you plan to protect food products from possible contamination, photographs of structural repairs that have been made since the inspection, and/or any other useful information 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 when you will correct any remaining violations.
Please send your response to the U.S. Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms. Norris at (407) 475-4730.
Director, Florida District