| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
June 30th, 2011
Ms. Mai Le Huynh, Owner
Mai's Bakery, Corp
1965 Potrero Grande Dr. Suite I
Monterey Park, CA 91754
WL# 46/11
Dear Ms. Huynh:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, Mai's Bakery, Corp, located at 1965 Potrero Grande Dr. Suite I, Montery Park, California, from March 22-28,2011. Your firm manufactures dessert products including Mochi, Moon Cakes, Rice Cakes, and Hopia. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice (CGMP) regulation for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110) at your facility. These violations cause your food products to be adulterated within the meaning of Section 402(a)(4) of Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.
You may find the Act and the CGMP regulations for food through links in FDA's home page at www.fda.gov.
The significant violations documented during the inspection include the following:
1. 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 investigators observed in your facility's warehouse:
• An opened bag of raw peanuts in a burlap sack, stored on top of a pallet containing bags of sodium benzoate.
• A plastic bag filled with burnt peanuts stored in an open cardboard box on top of a sack of raw red beans.
• Three bottles of flavorings stored next to bottles of cleaning detergent, bleach, and a toilet plunger.
2. Your firm failed to maintain utensils in an acceptable condition through appropriate cleaning and sanitizing, as necessary, as required by 21 CFR 110.80(b)(1). Specifically, our investigators observed:
• A dirty measuring cup and a dirty metal spatula stored on top of a box of uncapped soy bean salad oil.
• A dirty steam pan with green food residue on the inside mesh placed on top of a pot containing cooking sugar water "syrup" on a steaming stove.
• A stack of steam pans with a build up of food debris stored on a wooden rolling riser. These same pans were later observed used in the steaming of the rainbow cakes.
3. Your firm failed to handle work-in-progress in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically, our investigators observed:
• A small red alter with an incense tray and burned incense sticks located adjacent to a wok and stove used to prepare various products and directly above buckets used for holding in-process food products.
• Uncovered in-process mung bean paste stored in an open white unlabeled container in the walk in cooler. The paste was in the direct path of air flow from the cooler's condenser unit.
4. Your film failed to maintain containers used to convey, hold, or store raw materials, work-in-progress, rework, or food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically, our investigators observed:
• A gray trash can style container labeled as flour, hut which contained cooling sugar water "syrup". The container had a cracked lip and food debris on the handles. Additionally, a similar container located next to it had peeling plastic along the inside bottom surface. That container is also used to hold sugar water "syrup" used in the manufacture of a majority of your products.
5. Your firm failed to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination, as required by 21 CFR 110.35(d)(3). Specifically, our investigators observed:
• Food debris build up on the front and back areas and knobs of the stove; on the surfaces of the five steaming stoves; on the surfaces of the fire mixer including the control knobs and mixing attachment connection; and on the surfaces of the Hobart stand mixer.
• Food residue and debris on the shelves below the wooden production table. A used baking liner and soiled/stained rags were also stored on the shelves.
• Peeling plastic tape on doors of the two steaming ovens.
6. Your firm failed to provide adequate hand-washing facilities, as required by 21 CFR 110.37(e). Specifically, the hand-washing station in the production room was not equipped with paper towels or any other drying device, and the soap dispenser in the warehouse bathroom was empty.
7. Your management failed to take all reasonable measures and precautions to ensure that all persons working in direct contact with food, food contact-surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against the contamination of food, as required by 21 CFR 110.10(b). Specifically:
• Employees did not wash their hands thoroughly after each absence from the work station and at any time their hands may have become soiled or contaminated [21 CFR 110.10(b)(3)]. Specifically, our investigators did not observe employees washing their hands at any time while working in the production room on 03/22/2011, including when employees returned from break outside of the production room.
• Employees did not maintain gloves used in food handling in an intact, clean, and sanitary condition [21 CFR 110.10(b)(5)]. Employees wearing disposable gloves were observed touching both food contact and non-food contact surfaces while wearing the same pair of gloves.
• Employees failed to wear hair nets, caps and beard covers, where appropriate, in an effective manner [21 CFR 110.10(b)(6)]. Several employees were observed wearing hair nets that did not fully cover their hair and two employees with beards were not wearing any beard nets while handling food.
• Employees failed to confine drinking beverages to areas other than where food may be exposed [21 CFR 110.10(b)(8)]. Our investigators observed a partially consumed cup of ice coffee stored inside of the raw ingredient cooler directly above a partially covered bucket of raw materials.
6. Your firm failed to properly identify and store toxic materials in a manner that protects against contamination of food and food-contact surfaces, as required by 21 CFR 110.35(b)(2). Specifically, on 03/22/2011, we observed an unlabeled spray bottle, later identified as grill and oven cleaner, stored under the 3-compartment sink and three bags of technical grade borax, used for cleaning stoves/oven, stored next to cardboard boxes containing food packaging materials (white plastic trays). On 03/23/2011, we observed an unlabeled white 1-gallon bottle, later identified as bleach, under the 3-compartment sink.
7. Your firm failed to use sanitizing agents under safe conditions of use as required by 21 CFR 110.35(d)(5). Specifically, on 03/23/2011, our investigators observed that the diluted chlorinated bleach used for sanitizing pans and plastic containers had a chlorine concentration greater than 200 ppm, which could cause the residue to become a food contaminant.
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
In addition, all food manufacturing, including packaging and storage, must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). Samples collected for pH and water activity during the inspection found that your products which are stored, and distributed at ambient temperature, including Mung Bean Mochi, Rainbow Cake, Banana Cake, and Sweet Rice Cake, as currently formulated will support the rapid growth of undesirable microorganisms when held at such temperatures. A summary of the sample results is included below:
• 642473 Rainbow Cake, (b)(4)
• 642474 Mung Bean Mochi, (b)(4)
• 649583 Banana Cake, (b)(4)
• 649548 Sweet Rice Cake, (b)(4)
FDA recommends refrigerating these products for safety, or reformulating them to minimize the potential for the growth of microorganisms when stored at ambient temperatures. You should also evaluate your other similar products and take the actions necessary to ensure the products are safe under the conditions of storage and distribution.
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
We request that you notify this office in writing within 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. In your response, include documentation of your corrective actions or steps towards long term, corrective action, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
Blake Bevill
Director Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
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