Inspections, Compliance, Enforcement, and Criminal Investigations
Sincere Orient Commercial Foods Corp. 7/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
Via UPS Overnight
July 13, 2012
Mr. Andrew Khun, President
Sincere Orient Commercial Foods Corp.
15222 Valley Boulevard
City of Industry, CA 91746-3323
Dear Mr. Khun:
The Food and Drug Administration (FDA) conducted an inspection of your food storage and processing facility, located at 15222 Valley Blvd., City of Industry, California, from February 23 through March 01, 2012. During the inspection, FDA investigators documented 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). The inspection also determined that your firm is engaged in the processing of acidified foods but has not registered as a commercial processor of acidified food, nor filed scheduled processes with FDA for your acidified foods as required. 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 conditions cause the foods processed and stored at your facility to be 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)] because these food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
The following violations were observed during the inspection:
Specifically, our inspection of your facility revealed the following significant violations:
1. Your firm failed to register information with the FDA including: the name, place of business, and the location of the processing establishment within 10 days after engaging in the manufacture, processing, and packaging of acidified foods as required by 21 CFR 108.25(c)(1). Specifically, your firm has been manufacturing an acidified product, Banh Canh Vietnamese Noodle, without registering the aforementioned information with the FDA.
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 the acidified food products that you manufacture, specifically Banh Canh Vietnamese Noodle.
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 your processed acidified food product specifically Banh Canh Vietnamese Noodle. Without frequent testing of results, you cannot ensure that the finished equilibrium pH values of your product is not higher than 4.6.
Your product Banh Canh Vietnamese Noodle (Net Wt. 15 oz. package) is a packaged product that is labeled as "Refrigerated After Opening" and has a water activity of (b)(4). In order to keep this product from rapidly producing microorganisms of public health concern at ambient post-production temperatures, you are formulating the product with (b)(4) including (b)(4). In addition, you have developed product specifications to formulate the pH of the Vietnamese Noodle product to (b)(4), as verbally stated to our investigator during the inspection. However, our investigator found that you were not keeping daily batch control records and/or daily finished product testing records during the inspection to ensure that the pH of the finished product is monitored as required.
Your written response dated March 15, 2012 stated "the quality control technician is now in charge of monitoring pH levels (b)(4), documenting results, and informing upper staff of any irregularity." Your response is inadequate in that it does not describe how your facility will comply with the acidified food regulation.
4. Personnel involved in acidification, pH control, heat treatment, and critical factors were not under the operating supervision of a person who has attended, and satisfactorily completed, a school approved by the Commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls and critical factors in acidification as required by 21 CFR 108.25(f). Specifically, none of your personnel has attended and satisfactorily completed training at a school approved by the Commissioner.
5. Your firm must ensure that each acidified food 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, you stated that containers of Banh Canh Vietnamese Noodle would be marked with an expiration date if a customer requires one.
6. Your firm failed to prepare and maintain current procedures for: recalling products that may be injurious to health; identifying, collecting, warehousing, and controlling products; determining the effectiveness of recalls; notifying FDA of any recalls; and implementing recall programs as required by 21 CFR 108.25(e).
7. As required by 21 CFR 110.10(a), any person who is shown to have, or appears to have an illness, open lesion, including boils, sores, or infected wound; or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food packaging materials becoming contaminated, shall be excluded from any operation which may be expected to result in such contamination until the condition is corrected. However,
- On 02/23/12, a processing employee at the packaging stage for cooled "Fresh Rice Stick Noodle" handling in-process noodles with her bare hands exhibited a cut on the underside of her left hand that had a red appearance;
- On 02/28/12, an employee handling cooled "Fresh Rice Stick Noodle" sheets exhibited a cut with a red appearance on the top of her hand.
Your written response states that you only "informed," as opposed to directed, production managers to check hands, and merely "offer" gloves to employees with any wounds or markings. You did not indicate employees have been trained to wear gloves to cover wounds, that the wearing of gloves to cover wounds is required, or that the checking of hands has been implemented.
8. You must maintain toilet facilities in a sanitary manner, in order to comply with 21 CFR. 110.37(d)(1). However, on 02/23/12 waste paper with what appeared to be fecal matter on it was in the trash can in the restroom used by processing employees located in the warehouse in this same restroom, no soap or toilet paper was present.
Your written response, dated March 15, 2012 is inadequate in that you did not address the lack of soap and toilet paper in the restroom.
9. You must ensure that all persons working in direct contact with food conform to hygienic practices to extent necessary to protect against contamination of food, including wearing suitable outer garments, to comply with 21 CFR 110.10(b)(1). However,
- On 02/23/12 an employee handling cooled "Vietnamese Noodle" was observed with a bandage on her bare hands, stating she was wearing it to prevent injury. The employee removed the bandage revealing no wound behind it;
- On 03/01/12, two employees handling in-process cooked noodles were allowing these noodles to come in direct contact with their jeans while they collected the noodles from the conveyor belt for transfer to the next processing operation.
Your written response states that you will provide aprons that will cover areas with high potential contamination "in that particular section." Your response is inadequate in that suitable outer garments must be worn for any operation in a manner that protects against the contamination of food, food contact surfaces, or food packaging materials, and you did not state that this correction had actually been performed. Further, the use of this bandage during processing does not appear to be a sanitary practice, as the bandage would be difficult to clean properly, and may promote a source of cross contamination from insanitary objects to food during processing.
10. You must clean and sanitize food-contact surfaces in wet-processing after any interruption during which they may have been contaminated, to preclude contamination with microorganisms, to comply with 21 CFR 110.35(d)(2). However, on 02/24/12 on equipment used to manufacture "Oriental Rice Noodle'',
- Your firm did not use sanitizer on any of the food contact surfaces previously cleaned and used to manufacture "Oriental Rice Noodle" and "Vietnamese Noodle";
- An elbow connector for the noodle extruder was placed on the floor and not subsequently cleaned and sanitized prior to being placed back on the extruder intake.
Your response states you designated one line to stop production for one day to clean and sanitize, and employees will be taught to properly degrease and sanitize all areas that come in contact with food. This is not adequate since proper cleaning and sanitizing is required for all food contact surfaces, and your cleaning procedure does not state it has been implemented.
11. You must maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated within the meaning of the Act, and to comply with 21 CFR 110.35(a). In addition, you must clean and sanitize utensils and equipment in a manner that protects against contamination of food, food contact surfaces, or food-packaging materials. However,
- On 02/23/12, a noodle strainer no longer used for food processing and encrusted with a white grayish colored residue was in a puddle in the corner of the warehouse above pipes that extend through the ceiling;
- On 02/28/12, a white grayish colored residue encrusted the fans that blow air on the liquid rice mixture as it enters the oven and on the fans that blow air on the uncut sheets of cooked noodles as they exit the dryer; a white grayish colored residue encrusted the pipe that carries steam to the driers in the production room;
- On 03/01/12, a white grayish colored residue encrusted the three compartment sink located in the processing room where the "Fresh Rice Stick Noodle" is manufactured and used to clean processing equipment.
We acknowledge your written response states, "All fans will be wiped down and cleaned after and before future use," and the encrusted filth on the pipe that carries steam to the driers and the encrusted filth on the 3-compartment sink will be cleaned. Your response is inadequate in that it did not state that these connections had actually been performed or provide a time frame for correction.
12. You must take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). However, you failed to exclude pests from areas of your facility, including production areas where noodle products are manufactured. Specifically,
- On 02/23/12, three flying insects were in the pump room, which has incomplete walls that do not reach the ceiling shared with the warehouse. In addition, the loading dock door outside the pump room was open to the outside;
- On 03/01/12, three live birds were in the warehouse flying over the raw materials used to manufacture "Fresh Rice Stick Noodle," "Oriental Rice Noodle," and "Vietnamese Noodle."
Your written response that states you "must vacuum the floors of any wet areas that attract insects" and that you have contacted pest control. We do not consider this to be an adequate response since you have not stated what corrections, if any, to the pest problems, has been implemented or provided a time frame for taking action to control pests.
13. Your plumbing must be adequately designed, installed and maintained to avoid being a source of contamination to food, water supplies, equipment, or utensils, or creating an unsanitary condition, to comply with CPR. 110.37(b)(5). This includes providing that there is not backflow from, or a cross-connection between, piping systems that discharge waste water or sewage and piping systems carry water for food or food manufacturing. However, our investigator observed the following:
- On 02/24/12, the water intake pipe was observed extending below the flood rim on the boiling tank used for the "Oriental Rice Noodle" and "Vietnamese Noodle";
- On 02/28/12, the water intake pipes were observed extending below the flood rim on the three tanks used to rinse and soak rice for the "Oriental Rice Stick Noodle." On the middle tank the water level was observed above the bottom of the water intake line;
- On 2/24/12, the hose with a nozzle that is used to rinse food contact surfaces and comes in contact with food contact surfaces was observed without a backflow device on it. The investigator observed this nozzle used in direct contact with the elbow connector for the noodle extruder to dislodge noodle residue during cleaning;
- On 02/24/12, each of the film's four boilers had only a single check valve on each of their water intake lines.
Your written response states you would meet FDA standards by cutting these water intake pipes, however no timeframe was given for completion. Regarding the corrective actions for the backflow device on the hose with the nozzle and the single check valves on the boilers, your response was unclear. Please describe your correction regarding these observations in your response to this letter.
14. Your plant must be suitable in construction and design to facilitate maintenance and sanitary operations for food manufacturing purposes, including providing sufficient space for materials, to comply with 21 CPR 110.20(b)(1). However, our investigator observed your raw material warehouse containing pallets of rice where stored so closely together to allow only approximately 3 inches of space between pallets. This arrangement does not allow for proper cleaning and inspection of these raw materials to determine if they are being stored in a sanitary manner.
We do not consider your response adequate since you did not indicate that any correction would be performed regarding this violation, citing loss of warehouse space that would occur if the warehouse inventory was re-arranged to allow for space between each row, and possible "employee safety" issues.
15. All plant equipment and utensils shall be so designed and of such workmanship as to be adequately cleanable, and shall be properly maintained, to comply with 21 CFR 110.40(a). In addition, you must ensure that the design, construction, and use of equipment and utensils preclude the adulteration of food with lubricants or any other contaminants. However, our investigator observed the following during the production of your noodle products:
- On 02/28/12, dirty retail packaging bags were observed taped to the end of the pipe that fills rice into the rice grinders;
- On 02/28/12, a piece of string was observed tied to a screw on the conveyor that transports the rice liquid into the oven. This string was in contact with the rice liquid.
Your written response is inadequate since, while your firm has replaced the tape holding bags with zip ties, no evidence is provided that the zip ties are more sanitary than tape, and you have not indicated that disposable bags have already replaced the dirty retail packaging bags.
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:
The above items are not intended to be an all-inclusive list of the objectionable conditions and/or practices in your facility. It is your responsibility to ensure that your establishment and your food products comply with the Act and its implementing regulations. You should take prompt action to correct all violations of the CGMP and Acidified Foods regulations noted above. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to seizure and/or injunction and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence, including detailed information of the terms of your pest control service, steps you have taken to monitor screening or other protection against the entry of pests on an ongoing basis, and any employee training. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact: Robert McNab, Compliance Officer at 949-608-4409.
Alonza E. Cruse
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-741