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WARNING LETTER

T&W LLC MARCS-CMS 579386 —


Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
Ms. Wendy O.P. Fu
Recipient Title
Owner
T&W LLC

349 Broadway
Millbrae, CA 94030
United States

Issuing Office:
Office of Human and Animal Food Division 5 West

1431 Harbor Bay Parkway
Alameda, CA 94502-7070
United States


WARNING LETTER

Sent Via UPS
Signature Required

August 6, 2019

WL #579386

Ms. Wendy O.P. Fu, Owner
T & W LLC
349 Broadway
Millbrae, CA 94030

Dear Ms. Wendy O.P. Fu:

The U.S. Food and Drug Administration (FDA) inspected your airline catering facility, located at 349 Broadway, Millbrae, CA, on March 04-06, and 08, 2019. During the inspection, the FDA investigator documented serious violations of the current Good Manufacturing Practice (cGMP) Regulations, Title 21, Code of Federal Regulations, Part 117 (21 CFR 117). We acknowledge receipt of your email response, received April 1, 2019, addressing our investigator’s observations of concern. Your April 1st response included various corrective actions already taken and other corrections scheduled to be completed by your firm. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations.

Based on FDA’s inspectional findings and assessment of your response, the prepared meals you manufacture are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they are prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, FDA conducted a review of the labeling of your prepared meals as inflight meals and found significant violations of the labeling regulations for foods, 21 CFR 101. These violations cause your meals to be misbranded within the meaning of section 403 of the Act, [21 U.S.C. §343]. You may find the Act and these regulations through links in FDA’s home page at www.fda.gov.

Your significant violations are as follows:

Adulteration

1. You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food, as required by 21 CFR 117.80(c)(2).

a) On March 4, 2019 the investigator observed a fly-like insect in an open container of sugar. You are responsible for ensuring ingredients are properly stored to protect against contamination.

Your response indicates you will post signs to remind employees to cover ingredients with a completion date of August 31, 2019. We are unable to evaluate the adequacy of your response since your completion date is not until August 31, 2019, and you provided no substantive information to demonstrate how you plan to implement the corrections.

b) On March 4, 2019, the storage racks in the vegetable freezer were observed with black debris which appeared to have fallen on the uncovered ready to use peeled and sliced onions stored between the racks.

Your response did not indicate how cleaning of storage racks will be conducted and how you will ensure the stored products are not contaminated.

2. You did not provide hand-washing facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient and furnishing running water at a suitable temperature, as required by 21 CFR 117.37(e).

Specifically, employees have to go through two doors after handwashing and touch the door handles covered with cloth and tape, which cannot be adequately cleaned, to enter the preparation room. Additionally, the handwashing sink, which was installed 2 weeks prior to the inspection, was observed with no running water. Hand washing should be done before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3).

We also observed an employee, carrying a box of eggplant, touch their hat on their head and then begin cutting vegetables without changing gloves or washing hands. The investigator also observed an employee handle ready-to-eat pumpkin mushroom noodles after touching multiple non-food contact surfaces without changing their gloves and/or washing their hands.

Your response indicates you are still working on connecting a water line to the new sink, therefore, we are unable to evaluate the adequacy of your response at this time. You also indicate, until such time it is fixed, there are small bottles and paper towels on the side of the sink. This response is inadequate in that bottles and paper towels are not a substitute for handwashing and the response did not clearly state what kind of liquid would be in the bottles. Your response also states you have had a “CHANGE-MEAL-CHANGE-GLOVE POLICY” since 2018. We are unable to evaluate the adequacy of your response since you did not provide any documentation of this policy. You also stated that you will permanently remove the tape and cloth from the doors, which we will evaluate during the next inspection.

3. You did not clean and sanitize your utensils and equipment in a manner that protects against contamination of food, food contact surfaces, or food packaging materials, as required by 21 CFR 117.35(a).

Specifically, the investigator observed your third-party grease pit cleaner place the grease pit cover in direct contact with clean ready to use utensils. Additionally, the investigator observed overspray from grease pit that splattered onto ready to use utensils, plates and bowls used in daily preparation of the airline food. Splatter from the floor onto cleaned equipment and utensils is a prime source of pathogen contamination. You must protect cleaned equipment and utensils from any source of contamination that may adulterate food.

Your response states you have discussed the grease pit cleaning process with your contractor and will consider using a tarp to protect against splatter. This will be evaluated during the next inspection.

4. Your plant is not constructed in such a manner that floors, wall and ceilings may be adequately cleaned and kept clean and in good repair, as required by 21 CFR 117.20(b)(4).

Specifically, your production room floor has cracked tiles, uneven surfaces and a porous cement section with pooling water under the stove. The floor does not allow for adequate cleaning and this could attract pests.

During the inspection, you stated that the tiles will be replaced by the end of March 2019. Your April 1 response is inadequate as you did not address the issue with pooling water under the stove or confirm that the tiles have been replaced. We acknowledge your response that the kitchen will be cleaned weekly and everything will be removed for the cleaning and documented. This corrective action will be evaluated during the next inspection.

5. You did not clean non-food contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials as required by 21 CFR 117.35(e).

Specifically, the investigator observed grease build-up on the exhaust fan above the stove, and on the top, sides and underneath the stove, which you stated was cleaned every 3-4 months by a third-party cleaning company. Additionally, debris was observed on the refrigerator floor where food is stored. The investigator also observed debris on fans located above the preparation area where uncovered ready-to eat food was prior to use for airline meals. There was debris observed on the fans located in the freezer where uncovered food is stored.

This is a repeat observation from the previous inspection dated December 12-13 and 19, 2017. Your response to this observation is inadequate. You did not provide any information on the cleaning of freezer storage racks or the refrigerator floor. We acknowledge your submission of a photo of the area above the stove that appeared to have been cleaned by a vendor and will be cleaned every 3 weeks. You did not provide any documentation of the vendor’s agreement to conduct the scheduled cleanings. For the dust and debris inside the exhaust fans, you explained that you will remove the covers and scrub the panels. The expected date of completion is August 31, 2019 and these corrective actions will be evaluated during the next inspection.

6. You did not have a qualified individual engaged in manufacturing, processing, packing, or holding food who has received training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual’s assigned duties, as required by 21 CFR 117.4(b)(2).

Specifically, you told the investigator that the only training the employees receive is a ServSafe Food video; however, no records of completion were presented to the investigator. You told the investigator that no other training is provided.

You also indicated you will have the employees complete their annual training by August 31, 2019 and a Managerial Facility Food Certificate will be completed April 30, 2019. We are unable to evaluate the adequacy of your response since you indicate these will be completed in the future.

Misbranding

7. Your fish with ginger sauce meal product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product fails to bear labeling that declares the major food allergen, fish, as required by section 403(w)(1) of the Act. Note that the fish must be listed by an acceptable market name as in The Seafood List, FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce. The Seafood List reflects the views of FDA concerning the most appropriate common or usual names for the identification and labeling of seafood sold in interstate commerce.

8. Your fish with ginger sauce meal product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product fails to bear labeling with the common or usual name of the food. You manufacture the meal for sale to an airline caterer, who subsequently resells the product to airlines. However, the meals fail to bear labeling with a statement of identity as required by 21 CFR 101.3.

9. Your fish with ginger sauce meal product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because it fails to bear labeling with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

10. Your fish with ginger sauce meal product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product fails to bear labeling that lists all the common or usual names of each ingredient used as required by 21 CFR 101.4.

11. Your fish with ginger sauce meal product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the product fails to bear labeling with the net quantity of contents as required by 21 CFR 101.7.

This letter is not intended to be an all-inclusive list of the violations associated with your facility or your products. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and/or distribute. It is your responsibility to ensure the products you manufacture and/or distribute are following all applicable statutes and regulations, including the Act and applicable FDA regulations. You should take prompt action to correct all the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to correct and prevent these violations, or similar ones, may result in FDA taking regulatory action, including, without limitation, seizure or injunction.

Within fifteen (15) business days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

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 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. 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 re-inspection-related to 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 send your written response to the attention of

Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502

Please reference Case number 579386

If you have questions regarding this letter, please contact Tammy Hancock at 510-337-2922 ext. 103.

Sincerely,

/S/
Darla R. Bracy, District Director
Office of Human and Animal Food
Division 5 West

cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capital Avenue – MS7602
P. O. Box 997413
Sacramento, California 95899-7435