| Public Health Service Food and Drug Administration |
| Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 |
Department of Health and Human Services
Telephone (973)331.4900
February 10, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Shoji Ihara
Acting Vice President
Global Protein Foods, Inc.
170 Avenue L
Newark, New Jersey 07105-3831
11-NWJ-08
Dear Mr. Ihara:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 170 Avenue L, Newark, New Jersey, from October 13 through November 3, 2010. The inspection revealed that your soybean sprouts are 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 have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. In addition, the inspection revealed serious violations of FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These conditions cause the food products produced at your facility, including the soy beverages, tofu, and yuba, to also be adulterated within the meaning of section 402(a)(4) of the Act in that they have also been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. You can find the Act and its implementing regulations at www.fda.gov.
Your significant violations were as follows:
Insanitary Conditions
1. Your soybean sprouts are adulterated within the meaning of 402(a)(4) of the Act in that you prepared, packed or held them under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. Our investigator observed the following conditions and practices which may result in the contamination of your soybean sprouts with filth and pathogens:
• Finished soybean sprouts were stored in soiled blue plastic baskets and metal buckets.
• On 10/13/10 and 10/19/10, an employee was standing in the stainless steel sprout dump, also known as the sprout hopper, containing finished soybean sprouts. The employee was wearing the same boots he was observed wearing while walking throughout the facility. The boots were not sanitized.
• PVC and metal pipes above the finished soybean sprout line were dripping condensate onto the production equipment, the floors below, and onto a paper bag of soybean seeds used for sprouting in the receiving area.
• Soiled uniforms and aprons were being worn by employees handling finished soybean sprouts before packing.
• Employees on the packing line were handling soiled blue plastic baskets containing sprouts with bare hands, and did not wash and sanitize their hands after touching the buckets prior to resuming packing the soybean sprouts.
• Floor drains throughout the facility were clogged with product such as soybeans and soybean sprouts. Water was pooling in the clogged drains near wooden water tanks in the soybean sprouting area, and in the soybean sprout production area. Pooling water with organic matter fosters the growth of pathogens which may be transferred through splashing onto food or food contact surfaces.
• An employee was cleaning metal sprout pans using only soiled hot water from the dish machine without any soap or sanitizer.
• Water for sprout production flows through white fabric bags that are stained red with apparent rust and filth.
CGMP violations
1. You must maintain equipment and utensils used to manufacture food in an acceptable condition through appropriate cleaning and sanitizing, as necessary, including taking apart equipment as necessary to clean and sanitize properly, as required by 21 CFR 110.80(b)(1). However, our investigator observed the following:
• No sanitizer was used during any cleaning operation conducted during the inspection. The drum used to store bleach was empty.
• On 10/20/10 an employee cleaning the tofu line told our investigator that no sanitizer was being used.
2. You must ensure that plant equipment and utensils are of such material and workmanship as to be adequately cleaned and properly maintained, as required by 21 CFR 110.40(a). However, our investigator observed the following:
• Conveyor belts on the tofu production line were heavily stained, pitted, and exhibited a mold-like substance.
• The fryers used for frying tofu exhibited old caked-on product and grease residue on the surfaces of the fryer, with grease dripping into the oil used to fry tofu.
3. You must take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). However, our investigator observed the following:
• A dead mouse on the floor near an unused fryer unit stored in the tofu fryer room.
• Live flies, too numerous to count throughout the facility, including in production areas. The flies were landing on equipment and packaging materials.
• Live roach-like insects, too numerous to count, in an unused damaged vacuum sealer stored next to the label packaging table, which is near the sprout and tofu packaging tables.
• Rodent excreta-like pellets, too numerous to count, in the walk-in refrigerator next to finished tofu product, in the receiving area where soybeans used for tofu and soymilk are washed, behind pallets of bags of soybean seeds along the walls in the warehouse area, near stored unused pallets in the receiving area, on and next to bags of citric acid in the refrigerator room, and on the floor near the hand-washing sink in the production area.
• Styrofoam-like rodent nesting containing rodent excreta-like pellets in the walk-in refrigerator and near the hand-washing sink in the production area.
• Spider webs were throughout the facility, including in the receiving area on the overhead pipes, and a web containing a live spider was directly above the tofu production line.
4. Your firm failed to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Our investigator observed the following:
• Large gaps at the bottom of two bay doors on the receiving dock, three bay doors on the shipping dock, one exit door on the receiving dock, two bay doors in the tofu fryer room, and around an exit door on the receiving dock.
• The boiler room, which opens directly to the frying room, has a doorway to the exterior of the building covered only by an open metal grate with mesh large enough to permit pests to enter.
• Exhaust fans above the wooden water tanks which open to the outside of the building were not operating and lacked protective screening.
5. You must ensure that plumbing is of adequate size and design, and adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils, or creating an unsanitary conditions, as required by 21 CFR 110.37(b)(3). However, our investigator observed the following:
• Open equipment discharge pipes without a direct connection to drains caused pooling of water throughout the facility, including the soybean washing unit, the dish machine, and the pressure cooker, which drain directly onto the facility floor.
• The waste line connected to the pasteurizer used in soymilk and tofu production discharged into a clogged floor drain. There was no air gap or back flow prevention device between the waste line and the drain.
• A hand washing sink in the production area was leaking water onto the floor.
6. You must ensure that the plant buildings and structures are suitable in size, construction, and design to facilitate maintenance and sanitary operations. The facilities must be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair and that that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.20(b)(4). However, our investigator observed the following:
• PVC and metal pipes above production lines with exterior rust and mold-like contamination. The pipes were dripping condensate onto the production equipment and floors.
• Floors throughout the facility, including storage and production areas, were unsealed.
7. You must ensure that buildings, fixtures, and other physical facilities of the plant are maintained in a sanitary condition and kept in repair, as required by 21 CFR 110.35(a). However, our investigator observed the following:
• Facility walls exhibited mold and dirt.
• A door in the final hold walk-in refrigerator was damaged and exhibited chipped paint.
• A plastic curtain in the refrigerated room exhibited dirt and food residue.
8. You must ensure that toxic cleaning compounds, sanitizing agents, and pesticide chemicals are identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(b)(2). However, our investigator observed the following:
• On 10/13/10, (b)(4) Ant and Roach spray located near the pasteurizer used in soymilk and tofu production.
• On 10/19/10 drums of (b)(4) Fryer cleaner stored In the fryer room, approximately five feet from the fryer.
9. You must ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices necessary to protect against contamination of food, such as, wearing suitable outer garments to protect against the contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.10(b)(1). However, our investigator observed the following:
• Soiled uniforms and aprons being worn by employees and soiled aprons hanging in areas near packaging materials.
10. You must ensure that rubbish is conveyed, stored and disposed of to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding places for pests, and protect against the contamination of food, food-contact surfaces, water supplies, and ground surfaces, as required by 21 CFR 110.37(f). However, our investigator observed the following:
• A 30-cubic yard garbage compactor located near a bay door, emitting a foul odor and leaking liquid refuse onto the ground and into a clogged drain adjacent to the building. In addition, the same odor and flies too numerous to count were observed in the receiving area and soybean wash area which were located on the interior side of the bay door.
11. You must ensure that the grounds around the facility are kept in a condition that will protect against the contamination of food. This includes properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the structures that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.20(a)(1). However, our investigator observed the following:
• Numerous PVC pipes, wooden pallets, and other equipment stored under an unused trailer located near the bay doors. The trailer was located near the bay doors that were observed to have large gaps, as well as near the boiler room that was open to the outer environment and covered only by a metal grate.
• Unused equipment was stored outside on the ground and under trailers near the receiving dock.
• Overgrown weeds and shrubs were observed around the facility.
We acknowledge that on October 27 and October 28, 2010 you voluntarily destroyed all packaged and in-process soybean sprouts, all bottled soymilk, all packaged tofu, all packaged yuba, and fifteen 55-pound bags of soybeans which were held and processed at your firm.
For additional information and guidance for industry concerning sprouts, please refer to FDA's home page at www.fda.gov.
The above violations are not meant to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all of your products are in compliance with applicable laws and regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and prevent their recurrence. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be submitted to: Sarah A. Della Fave, Compliance Officer, US Food & Drug Administration, New Jersey District, 10 Waterview Boulevard, 3rd Floor, Parsippany, NJ 07054.
If you have any questions regarding any issue in this letter, please contact Ms. Della Fave at 973.331.4910.
Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District
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