- Delivery Method:
- Overnight Delivery
- Food & Beverages
Recipient NameMyong S. Bracy, Owner
Recipient TitleMyong S. Bracy, Owner
- Portland Sandwich Company
11131 NE Halsey Street
Portland, OR 97220
- Issuing Office:
- Division of Human and Animal Food Operations West VI
April 3, 2020
In reply, refer to: CMS 604342
Dear Ms. Bracy:
The U.S. Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) sandwich facility, located at 11131 NE Halsey Street, Portland, Oregon, from December 2, 2019, to December 6, 2019. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). FDA’s inspection resulted in issuance of an FDA Form 483 (FDA 483), Inspectional Observations, listing deviations found during the inspection. To date we have not received a response addressing the issues presented to you during the inspection and listed on the Form FDA 483.
Based on FDA’s inspectional findings, we have determined that the RTE products, including a variety of closed-face meat and cheese sandwiches manufactured in your facility, are 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 they were 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, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's Internet home page at http://www.fda.gov.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not conduct a hazard analysis for any of your products. Specifically, you did not identify and evaluate known or reasonably foreseeable hazards for each type of food products manufactured or processed at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a).
a. You did not identify and evaluate allergen cross-contact to determine whether it is a hazard requiring a preventive control. Your facility manufactures various products with different allergen profiles on the same day and on shared equipment.
b. You did not identify and evaluate undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Your facility receives, stores, and manufactures various products that contain allergens such as fish, milk, peanuts, and eggs.
c. You did not identify and evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, to determine whether environmental pathogens are a hazard requiring a preventive control to comply with 21 CFR 117.130(c)(1)(ii). Your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or downstream customer) that would significantly minimize the pathogen.
d. You did not identify and evaluate the biological hazard of bacterial growth due to a lack of time/temperature control during the storage of your variety of RTE closed-face meat and cheese sandwich products as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control.
e. You did not identify and evaluate biological hazards such as Salmonella as know, or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. Your facility manufactures/processes food with peanut butter. This ingredient has been known as a common source of a biological hazard (Salmonella).
f. You did not identify and evaluate chemical hazards such as mycotoxins as known, or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. Your facility manufactures/processes food with wheat bread and peanut butter. These ingredients have been known as a common source of a chemical hazard (aflatoxin).
2. You did not establish and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR 117.140).
Your “Egg Salad Sandwich HACCP Plan” dated February 15, 2018, only partially addresses this requirement, and you did not have HACCP plans for other foods that you manufacture.
3. You did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in your facility, as required by 21 CFR 117.126(a)(1). A food safety plan must include the following:
a. The written hazard analysis, as required by 21 CFR 117.130(a)(2);
b. The written preventive controls, as required by 21 CFR 117.135(b);
c. The written supply-chain program, as required by subpart G;
d. The written recall plan, as required by 21 CFR 117.139(a);
e. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR 117.145(a);
f. The written corrective action procedures, as required by 21 CFR 117.150(a)(1); and
g. The written verification procedures, as required by 21 CFR 117.165(b).
Current Good Manufacturing Practice (Subpart B):
1. All persons working in direct contact with food, food-contact surfaces, and food packaging-materials did not conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b). Specifically,
a. Employees were observed changing tasks without discarding their gloves and washing their hands. Specifically, employees at the sandwich preparation station were observed entering the walk-in cooler to retrieve an ingredient, bringing the ingredient back to their designated preparation station, and resuming sandwich assembly without discarding their gloves and washing their hands.
b. An employee with bare hands was observed picking up and consuming meat and cheese from one of the sandwich preparation stations while other employees were preparing RTE sandwiches.
2. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food, as required by 21 CFR 117.80(c)(2). Specifically,
a. A (b)(4) veggie wash container was stored on the floor underneath the food preparation sink. Employees were observed placing the veggie wash container on the food preparation sink while washing lettuce and other produce.
b. The bread rack trays containing debris and dirt residues were being used to store washed lettuce.
c. Employees were observed placing a box of meat directly on top of a food preparation station where sandwiches were being assembled.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the Act and FDA’s implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violations specified above may result in legal action without further notice, including seizure of violative products and/or injunction.
In addition to the violations described above, we offer the following comments:
You must establish and maintain records that document your employees 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 individuals’ assigned duties, as required by 21 CFR 117.4(d).
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 re-inspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021, to the attention of Tracy K. Li, Compliance Officer. If you have any questions concerning this letter, you can contact Ms. Li at (425) 302-0428.
Miriam R. Burbach
Program Division Director