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  1. Warning Letters

WARNING LETTER

Ramar International Corporation MARCS-CMS 608782 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Ms. Susan Quesada
Recipient Title
President
Ramar International Corporation

1101 Railroad Ave
Pittsburg, CA 94565
United States

Issuing Office:
Division of Human and Animal Food Operations West V

United States


WARNING LETTER


WL 608782

Dear Ms. Quesada:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) ice cream manufacturing facility, located at 1101 Railroad Ave, Pittsburg, CA from May 20, 2020, through June 5, 2020. This inspection was initiated in response to your firm’s voluntary recall of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream (Best Before 10/08/2021), due to findings of Listeria monocytogenes (L. monocytogenes) in the product. During our inspection of your facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). In addition, during the inspection, FDA investigators collected environmental samples (i.e., swabs) from various areas in your facility. FDA laboratory analyses of the environmental swabs found the presence of L. monocytogenes, a human pathogen, in your facility.

Based on FDA’s inspectional findings and analytical results for the environmental samples, we determined that the RTE ice cream manufactured in your facility is 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 it has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it 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 on FDA’s homepage at www.fda.gov.

On June 26, 2020, we received your written response to the FDA-483, which describes your completed and planned corrective actions. After reviewing the inspectional findings and your written response, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

Your hazard analysis did not identify a known or reasonably foreseeable hazard that requires a preventive control, as required by 21 CFR § 117.130(a)(1). Specifically, you did not appropriately evaluate environmental pathogens to determine whether they are a hazard requiring a preventive control in accordance with 21 CFR § 117.130(c)(1)(ii). You manufacture ice cream, an RTE food product that is exposed to the environment at several processing steps where it could be contaminated with environmental pathogens, such as L. monocytogenes, and the ice cream does not receive a subsequent control for environmental pathogens. Specifically, during your “Mixing” and “Blending of Inclusions” processing steps, RTE ingredients (such as purees, inclusions, flavors, and colors) are added to RTE ice cream products post-pasteurization where they are exposed to the environment before being packaged. Your Hazard Analysis for “Magnolia Frozen Ice Cream,” dated June 29, 2019, which covers all ice cream products manufactured at your facility, indicates “ None” for potential biological food safety hazards at the “Mixing” and “Blending of Inclusions” processing steps, but you did not include an evaluation of environmental pathogens, even though you produce an RTE food exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Your rationale for concluding that you have no potential biological food safety hazards at the “Mixing” and “Blending of Inclusions” processing steps is based on, among other things, consideration of your Sanitation Standard Operating Procedures (SSOPs). Therefore, you inappropriately determined that there are no biological hazards that require a preventive control at these steps because of control measures you are using. Sanitation controls for environmental pathogens are necessary when RTE foods are exposed to the environment and there are no subsequent steps that would significantly minimize the hazard.

Environmental swabs collected during the inspection by FDA on May 21, 2020, detected L. monocytogenes at the following locations:

• Bottom left corner of the door between the (b)(4) freezer and RTE Production Room

During the inspection investigators observed employees moving from the (b)(4) freezer through this door to the RTE Production Room. Various electrical cords were observed lying on the floor in the RTE Production Room. During the walk-through of sanitation operations on June 2, 2020, investigators observed the same cords draped over pieces of equipment, including the (b)(4) freezer conveyor. You swabbed the (b)(4) freezer conveyor on April 3, 2020, and April 15, 2020, and found Listeria spp. both times.

• Bristles of a broom that was observed propped up against a ladder and wall in the Cooler Passageway Room

During the inspection investigators observed an employee using this broom to sweep water in the RTE Production Room during manufacturing operations. This area includes the same employee foot path described above. Employees repeatedly walked across this floor area and other areas of the RTE Production Room. Additionally, during the inspection investigators observed two other brooms stored with bristles in contact with the wet Cooler Passageway Room floor. Investigators then observed a sanitation employee bring one of the brooms into the RTE Production Room on two separate occasions to sweep coconut strings up from two drains. These same drains were swabbed during your environmental sampling on April 3, 2020, and were found positive for Listeria spp.

Whole genome sequencing (WGS) was conducted on three (3) L. monocytogenes isolates (two of three locations are described above and the third isolate was from an exterior ground drain) which were obtained from the FDA environmental sample INV 1109268 collected on May 21, 2020 during our inspection. The WGS analysis determined that the isolates represent a single strain of L. monocytogenes. These isolates are also genetically identical to one (1) clinical isolate collected in 2019, which indicates this strain has the capability of causing human illness. We advised you of those WGS results via a conference call on June 24, 2020.

Furthermore, reviewing your environmental monitoring program, we note that you have repeatedly found Listeria spp. in your processing facility. Specifically, on April 3, 15, and 20, and May 15, 2020, you conducted environmental swabbing which resulted in recurring findings of Listeria spp. in your RTE Production Room. Some of these findings were in repeat locations, including the pint filler conveyor and (b)(4) freezer conveyor. In response to each of these findings, you took similar corrective actions (which included ceasing production, cleaning and sanitizing your equipment and production area, implementing changes to cleaning programs, and re-testing sites). However, it appears that your corrective actions were not adequate to address your findings, as evidenced by the recurring findings of Listeria within your environment, including some within the same locations.

On May 12, 2020, you initiated a voluntary recall of your Peekaboo brand Mint Chocolate Chip with Hidden Spinach Ice Cream (Best Before 10/08/2021) that was manufactured on April 8, 2020, after your internal testing detected L. monocytogenes in the product. Further, after the recall and during the FDA inspection, your environmental swabbing on May 20-22 also detected Listeria spp. in three locations, including a drain in your RTE Production Room.

You identified improper employee handling of boxes of chocolate chips that were transported into the RTE Production Room via dollies and placed on the floor before being added to the (b)(4) machine as the root cause of L. monocytogenes finding in the recalled lot of Peekaboo brand ice cream. Your corrective actions included prohibiting the use of floor dollies on the production floor and replacing them with a (b)(4) cart for transporting and holding inclusions in the RTE Production Room. However, on May 21, 2020, this cart was observed sitting outside the building with one of its wheels in standing ground water. You swabbed this ground surface on May 21, 2020, and the result was positive for Listeria spp. On May 27, 2020, this cart was observed inside the RTE Production Room and you did not have a process for cleaning and sanitizing it when bringing it from the outside into the RTE Production Room.

These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

You committed to performing corrective actions in your written response dated June 26, 2020. Your written response indicates that you hired a consultant, performed intensified cleaning and sanitizing of your production area and equipment, implemented a test and hold program for finished products, and conducted GMP training for employees. Your response also indicates that you are working to revise your food safety plan (including your SSOPs and environmental monitoring program), reassess the hygienic zoning of traffic flow from production areas to non-production areas (including restricting carts to production areas), and make structural facility changes. Your response states that you will complete a hazard re-assessment that includes recontamination as a reasonably foreseeable hazard that requires a preventive control, as well as an ingredient “risk assessment” by July 31, 2020. Additionally, you state that you will complete revisions and assessments to your SSOPs and your Environmental Pathogen Sampling Corrective Action SOP along with employee training by September 14, 2020, and provide bimonthly updates on your progress. Although you provided a summary of the corrective actions that you have taken, your response does not include documentation of the implementation of your corrective actions, updated programs and procedures, and records demonstrating the effectiveness of your corrections. Specifically, your response does not include documentation such as steps taken to identify and correct the problems, environmental swabbing results since the close of the inspection, results of your microbiological test and hold program for finished products implemented on May 25, 2020, training records, or your revised hazard analysis and preventive control program. We recommend that you continue to implement these corrective actions to ensure that L. monocytogenes does not contaminate your RTE food products. To date, no additional updates or responses have been received. We will verify the implementation and adequacy of these corrective actions during our next inspection.

Current Good Manufacturing Practice (Subpart B):

1. 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). Further, your “GMP 2019” procedure states that “Drip or condensate from fixtures, drains or pipes must not be allowed to fall into and contaminate food, ingredients, food contact surfaces or food packaging materials.” However, the following conditions were observed during the inspection:

a. Liquid build-up was dripping from the (b)(4) filler hose directly onto a box of exposed finished product container lids that were being used to package the Magnolia branded Ube Ice Cream (Best By 05/20/2021).
b. Apparent liquid drops from a previous cleaning operation observed on the rear railing of the (b)(4) which is above and in close proximity to the openings of (b)(4) tanks which contained (b)(4) at the time. This (b)(4) was used in the production of Magnolia brand Ube Ice Cream (Best By 05/20/2021).
c. During the production of Magnolia branded Buko Pandan Ice Cream (Best By 05/27/2021), liquid build-up on the hose from the (b)(4) Ice Cream Machine was dripping above and in close proximity to the front auger opening of the (b)(4) Machine where Buco Strings Preserved (Production Date 12/6/2019; Best By 12/5/2020 were exposed.

Your response states that you have installed a (b)(4) to protect packaging, product, and food contact surfaces from drip and positioned outfeed hoses to minimize the potential for dripping, and that you plan to reduce condensation (b)(4). Your response also states that you have updated your sanitation checklist to include fixtures, drains, and pipes. Although your response included photos of the physical improvements, you did not provide evidence of the implementation and training of employees on your new procedures. We will verify the implementation and adequacy of these corrective actions during our next inspection.

2. You did not keep the grounds in a condition that would protect against the contamination of food, as required by 21 CFR § 117.20(a). Specifically, your operations involve transporting ingredients from a warehouse located in a separate building to the RTE Production Room. Your “GMP 2019” states “Maintain yard, parking lot and drainage in good repair so they do not attract pests or be a source of contamination.” However, on May 20, 2020, Investigators observed that the ground area located outside within the path where materials and ingredients are transported from the warehouse to the RTE Production Room was in disrepair. Specifically, the area outside of the RTE Production Room roll-up and man doors included gravel and pooled/standing water. This is also the designated area for the cleaning and sanitation of plastic pallets, black trash bins, and gray ingredient thaw bins before they are brought into the RTE Production Room.

Your response indicates that you have replaced the gravel with concrete, installed sanitizer (b)(4) units at doorways, and required that wheels of carts, hand trucks and forklifts be periodically sanitized to further minimize the potential for the introduction and spread of Listeria in the facility. Although your response includes photos of the physical improvements, you did not provide evidence of implementation and training of employees on your new procedures. We will verify the implementation and adequacy of these corrective actions during our next inspection.

3. You did not take reasonable measures and precautions to ensure 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 contamination of food, as required by 21 CFR § 117.10(b). Specifically, on May 20, 2020 (the first day of the inspection), there was no sanitizer available at the RTE Production Room handwash sink.

Your response states that you have added hand sanitizer containers at each hand washing station and will verify that sanitizer is available (b)(4). Your response also includes a copy of refresher training given to your employees on June 15, 2020. We will verify the implementation and adequacy of these corrective actions during our next inspection.

4. You did not clean and sanitize 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). Investigators observed the use of a high-pressure hose during cleaning and sanitizing of floors and equipment, leading to overspray on equipment that comes into direct contact with RTE ice cream products. Specifically:

a. A sanitation employee was observed using a high-pressure hose to spray drained cream on the floor towards a floor drain, causing water and contents from the floor to be sprayed back up onto the (b)(4) Machine. The employee also used the high-pressure hose to spray his boots while in close proximity to the previously cleaned (b)(4) Machine. The floor drain, near where the hose was being sprayed, was found positive for Listeria spp. during your (b)(4) environmental sampling on May 21, 2020.

b. Employees were observed using a high-pressure hose to spray the drained sanitizer contents from a (b)(4) tank on the floor towards a floor drain, causing splash to hit an empty gray cart. This same drain was found positive for Listeria spp. on April 3, 2020. The gray cart had previously been used to hold parts of the (b)(4) Machine prior to transfer to the (b)(4) tank. After being cleaned in the (b)(4) tank, the parts were placed back onto this dirty gray cart. Additionally, investigators observed a product filler hose partially fall onto the uncleaned floor from the same gray cart, exposing the opening of the product filler hose to the floor while (b)(4) contents were being drained onto the floor and sprayed by a high-pressure hose. The product filler hose remained in direct content with the dirty floor for approximately 45 minutes before an employee placed it back onto the cart with other previously cleaned equipment. Inadequately cleaned and sanitized floors can serve as niches or harborages for L. monocytogenes in food processing facilities. Water splashing off such floors may be a potential source of L. monocytogenes on food contact surfaces which can ultimately contaminate finished product.

Your response states that you are training employees to not begin cleaning in a room until all clean equipment and carts have been removed from the room or fully covered with plastic sheeting. Your response also states you are investigating ways to no longer discharge food (b)(4) and to use (b)(4) to move food on the floor to drains. Additionally, your response indicates that you have ordered sanitary hose nozzles that restrict flow of water, that high-pressure hoses will be removed from the plant, and that your staff is receiving sanitation training on the risk of cross-contamination. However, your response does not include evidence of your revised procedures and of employee training. We will verify the implementation and adequacy of these corrective actions during our next inspection.

Additional Comments:
You thaw frozen ingredient-containing bags in a (b)(4) sanitizer solution. During production of Magnolia brand Ube Ice Cream on May 20, 2020, bags of Ube (b)(4) were observed being thawed in large bins containing such a sanitizer solution. The bags were not rinsed with water after they were removed from the sanitizer solution. While an employee filled the (b)(4) mixing tank with the (b)(4), excess sanitizer solution was observed dripping into the tank. (b)(4) is not intended to become a component of your ice cream products.

Your response indicates you are now using (b)(4) to remove excess sanitizer solution on the exterior of the bags before packaging is opened and product is introduced into the mixer. However, your firm should ensure that sanitizers are used according to the instructions and indications for use specified on the product label. Thawing frozen ingredient-containing bags of product in a sanitizer solution may present the potential for product contamination. We will evaluate your corrections during the next inspection.

This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or about 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.

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.

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. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

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 #608782

If you have questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer, at 510-337-6854 or clarice.ahn@fda.hhs.gov.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations West - Division 5

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

 
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