As part of its enforcements, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Recently released warnings to food companies about tahini products and seafood products.
Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has be given months to years to correct problems. Recently posted warning letters include the below.
Sunshine International Foods Inc. — Methuen, MA
Emile S. Maroun, owner
The FDA inspected the Sunshine Ready-to-Eat (RTE) tahini manufacturing facility located at 26 Spruce Street, Methuen, MA 01844-4336, from Jan. 30, 2019 through Feb. 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 the Federal Food, Drug, and Cosmetic Act (the Act) 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 is prohibited.
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 (redacted by FDA) Systems, (redacted) 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 (redacted) to “track the effectiveness of Sanitation Procedures.” The procedure specifies (redacted) 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 (redacted) 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 (redacted) 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 (redacted) system before resuming pasteurizer operations on February 6, 2019. Your SSOP for the (redacted) System states that the (redacted) System is to be run (redacted) of (redacted).
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 (redacted) system will be cleaned “(redacted) however, you do not address how you will identify when cleaning will be needed. Further, your (redacted) equipment procedure, provided with your March 29 response, does not indicate the equipment cleaning frequency.
Dandong Shenghai Foodstuff Co. Ltd. — Donggang Liaoning Sheng, China
Jin Tao, vice general manager
The FDA conducted an inspection of your seafood processing facility, Dandong Shenghai Foodstuff Co. Ltd. located at Youhao Road East, Qiaonan Economic Development Zone, Donggang, Liaoning, China 118300 on May 16-17, 2019. During that inspection, it found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of that inspection, the FDA investigator issued an FDA 483, lnspectional Observations, listing the observations made at your firm.
We acknowledge receipt of your response sent via email on June 4, 2019. Your response included a HACCP plan entitled “Frozen short neck clam” dated May 23, 2019 and a document titled “Rectification report of nonconformity items.” However, our evaluation of your response revealed it was not adequate, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated. Accordingly, your frozen, cooked short neck clams are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
Your significant deviations are as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels. However, your firm’s revised HACCP plan entitled ” Frozen short neck clams,” dated May 23, 2019, does not list a container integrity critical control point to control the recontamination of pathogenic bacteria during cooling after the cooking process. FDA recommends processors ensure the cooling water contains residual chlorine or other approved water treatment chemical.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s revised HACCP plan entitled “Frozen short neck clams” lists monitoring procedures and frequencies that are not adequate. Specifically, your revised HACCP plan lists at the:
a. “(redacted)” critical control point, a monitoring frequency of “(redacted)” that is not appropriate to control natural toxins. FDA recommends you visually check incoming tags of every container.
b. “(redacted)” critical control point, a monitoring procedure and frequency that is not adequate to control pathogenic bacteria. Your revised plan indicates you will:
• Monitor the cooking tunnel water temperature using a “(redacted)“. FDA recommends monitoring batch cooking by using a continuous temperature-recording device installed where it measures the coldest temperature of the cooking equipment.
• Visually check the belt frequency (redacted). FDA recommends your firm’s monitoring procedures also list monitoring the belt speed, in addition to cooking water temperature. This may be measured with a stopwatch or tachometer to monitor the speed of the belt drive wheel; or a stopwatch to monitor the time
necessary for a test unit or belt marking to past through the equipment at least once per day and whenever any changes in belt speed are made.
3. Because you choose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). Your firm’s corrective action at the “(redacted)” critical control point is not an appropriate action to take when a critical limit is not met at receiving. Specifically, when supply certificate information is not on the label, the revised HACCP plan lists a corrective action of “(redacted).” In addition, FDA recommends that your corrective actions also include discontinuing use of that supplier until evidence is obtained that the supplier will comply with the certification controls.