- Food & Beverages
Recipient NameEmile S. Maroun
- Sunshine International Foods, Inc.
26 Spruce Street
Methuen, MA 01844-4336
- Issuing Office:
- Division of Human and Animal Food Operations East I
158-15 Liberty Avenue
Jamaica, NY 11433
Dear Mr. Maroun:
The United States Food and Drug Administration (FDA) inspected your Ready-to-Eat (RTE) tahini manufacturing facility located at 26 Spruce Street, Methuen, MA 01844-4336, from January 30, 2019 through February 19, 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 rule, [Title 21, Code of Federal Regulations, Part 117 (21 CFR 117)] (CGMP & PC rule).
Based on FDA’s inspectional findings and our assessment of your response, the RTE tahini products 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)] in that they were prepared, packed, or held under insanitary conditions 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 USC 331(uu)]. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
FDA’s inspection resulted in issuance of an FDA-483, Inspectional Observations, listing deviations found during our inspection. We received responses to the FDA-483 from you dated March 15, 2019 and March 29, 2019 (hereinafter “responses”) summarizing corrective actions taken by your firm. The adequacy of your firm’s implementation of those actions will be assessed during our next inspection. You also provided copies of the following documents: Hazard Analysis and Flow Chart for Repackaged RTE Flavored Tahini, Hazard Analysis and Flow Chart for Repackaged RTE Tahini, Cleaning Risk Assessment, SSOP Cleaning of Mixing Tank, SSOP Cleaning of Holding Tank, Cleaning and Sanitizing Report Form, SSOP for (b)(4) Systems, (b)(4) Equipment Procedure. We address your responses below.
We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
The following are significant violations of the CGMP & PC rule:
Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117, Subpart C):
1. Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a)(1). The hazard evaluation must include an evaluation of environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment, as required by 21 CFR 117.130(c)(1)(ii). Your RTE tahini products made from natural sesame seeds are exposed to the processing environment following pasteurization and prior to packaging, and your repackaged RTE tahini products are exposed to the processing environment throughout the processing of these products. Although you have identified “Microbial Growth Staphylococcus Aureus” as a potential significant food safety hazard in your hazard analyses for your RTE tahini products (including RTE tahini manufactured from natural sesame seeds with creation date 5-01-18, RTE flavored tahini manufactured from natural sesame seeds with creation date 5-01-18, repackaged RTE tahini with creation date 5-01-18, and RTE flavored tahini using raw tahini received at your facility with revision date 3-6-19), these hazard analyses do not identify contamination of RTE tahini with the environmental pathogen of Salmonella as a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether it is a hazard requiring a preventive control.
Although you state in your responses that you have updated your hazard analyses to include identifying contamination with environmental pathogens as a food safety hazard, the hazard analyses you provided for repackaged RTE tahini and RTE flavored tahini using received raw tahini do not identify environmental pathogens such as Salmonella as a known or reasonably foreseeable food safety hazard; the hazard analyses only identify “Microbial Growth Staphylococcus Aureus.” In addition, you did not provide revised copies of your hazard analyses for RTE tahini manufactured from natural sesame seeds and RTE flavored tahini manufactured from natural sesame seeds.
2. Your firm did not identify and implement a preventive control for a hazard when one was needed for your RTE products, as required by 21 CFR 117.135(a)(1).
a. Your food safety plans for RTE Flavored Tahini manufactured from natural sesame seeds, created 5-01-18, and for RTE Tahini manufactured from natural sesame seeds, created 5-01-18, do not identify pasteurization as a process preventive control to control the food safety hazard of pathogenic bacteria such as Salmonella. Salmonella is a known or reasonably foreseeable hazard requiring a preventive control in raw sesame seeds used to make tahini.
In your response provided on March 15, 2019 you stated that you have updated your food safety plans to “identify” pathogenic bacteria survival of a lethal treatment; however, we have not received updated copies of your food safety plans so we are unable to evaluate the adequacy of your changes.
b. You did not establish sanitation control procedures for cleaning and sanitizing of the portable filler that is used for filling RTE flavored tahini to address the food safety hazard of environmental pathogens. RTE food is exposed to the environment at this step and does not subsequently receive a treatment or otherwise receive a control measure.
Although you stated in your March 15 response that you have added a sanitation procedure for the portable filler, you did not provide that procedure in your response.
3. You did not establish and implement written corrective action procedures to be taken for environmental monitoring verification activities, to comply with 21 CFR 17.165(a)(3) and (b)(3)(vii) and 21 CFR 117.150(a)(1). Specifically, you did not establish corrective action procedures to be taken when non-food contact surfaces test positive for Salmonella. You have an environmental monitoring procedure (Standard Operating Procedure for (b)(4) to “track the effectiveness of Sanitation Procedures.” The procedure specifies (b)(4) testing them for the presence of Salmonella. Your “Environmental Monitor Log” describes corrective actions to take for a “presumptive positive result” for food contact surfaces, but no corrective actions are specified for non-food contact surfaces.
Your March 15 response states that “Corrective actions have been updated and implemented,” but does not include documentation as to how you will ensure appropriate corrective actions are taken in the future.
Current Good Manufacturing Practice (21 CFR 117, Subpart B):
1. All food-contact surfaces, including utensils and food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect again contamination of food, as required by 21 CFR 117.35(d). However, our investigators observed the following conditions:
a. Hardened tahini was present around the gasket between a stainless-steel pipe feeding from the hold/pasteurizer tank to the hopper for the retail jar filler located in the Pasteurizer/Filling/Packing Room.
b. Soft tahini was observed around and beneath the lid seams to the retail line filler hopper in the Pasteurizer/Filling/Packing Room.
c. Soft and hardened tahini were observed inside the retail line filler hopper and (b)(4) filler heads.
d. Soft tahini was observed inside the square mixer and grinding/milling hopper in the Roasting/Milling Room.
e. Chocolate tahini was observed inside the stainless-steel pipe feeding into the (b)(4) in the Pasteurizer/Filling/Packing Room.
In addition, your production records reflect the following:
f. After you used the pasteurizer on January 28, 2019, you did not run your (b)(4) system before resuming pasteurizer operations on February 6, 2019. Your SSOP for the (b)(4) System states that the (b)(4) System is to be run (b)(4) of (b)(4).
On March 29, 2019, you provided a “Cleaning & Sanitizing Report Form – Pre-Operational” to verify cleaning and sanitizing, and you provided a “Cleaning Procedures Risk Assessment.” However, you did not provide monitoring records demonstrating you are implementing adequate cleaning and sanitizing. Therefore, we are unable to fully assess the adequacy of your corrective actions. In addition, in your March 15 response you state that your (b)(4) system will be cleaned “(b)(4) however, you do not address how you will identify when cleaning will be needed. Further, your (b)(4) equipment procedure, provided with your March 29 response, does not indicate the equipment cleaning frequency.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws.
You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action without further notice, including without limitation, seizure, injunction, or administrative actions such as suspension of food facility registration if criteria and conditions warrant.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection 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 reinspection fees, [21 USC 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 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) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, 462 Welcome Center Road, Swanton, VT 05488. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or firstname.lastname@example.org.
Program Division Director
Office of Human and Animal Food Operations -
East Division 1