WARNING LETTER

Gondi S.A. MARCS-CMS 658698 — September 05, 2023

Delivery Method:: Via Express Delivery
Product:: Food & Beverages

Recipient:: Recipient Name

Mr. Carlos Villacis Guzman; Recipient Title

President and Owner; Gondi S.A.; Edificio Pireos Calle 17 Entre Calle 19 Y 20
Barrio Cordoba, Manta
Manabi
Ecuador; cvillacis@gondi.com.ec

Issuing Office:: Center for Food Safety and Applied Nutrition; United States

September 5, 2023

WARNING LETTER

Reference No. CMS 658698

Dear Mr. Villacis:

The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) product facility located at Km 5 1/2 Via Manta -Portoviejo, Conservas Ideal Plant (Industria De Enlatados Alimenticios Cia Ltda Ideal), Portoviejo, Manabi, Ecuador 130216 on April 10 through April 24, 2023. The inspection was initiated in response to FDA laboratory analysis of samples of your LACF seafood products which indicated the products may have been under processed, which could lead to the presence of spoilage organisms or pathogens.

During the inspection, we found that your firm had serious violations of the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious violations found at your firm. We received your response to the FDA-483 via email on May 12, 2023. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this Warning Letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

As a manufacturer of LACF products intended for export to the United States, you are required to comply with the Federal Food, Drug and Cosmetic Act (the Act) and applicable Federal regulations. Regulations specific to the processing of LACF products are codified in 21 CFR Parts 108 and 113. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113. For imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States (see 21 CFR 108.35(k)). Violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your LACF products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act and LACF regulations through links in FDA’s home page at www.fda.gov.

Furthermore, this letter is to inform you that FDA has placed your firm’s LACF products on Import Alert #99-38, “Detention Without Physical Examination of Low-Acid Canned Foods or Acidified Foods Due to Inadequate Process Control.” As a result, when your LACF products are offered for import into the United States, FDA may take steps to refuse admission, called Detention Without Physical Examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. The procedure is generally based on past history or other information, such as an establishment inspection, that indicates a product or products appear not to be in compliance with FDA’s laws and regulations.

This letter describes the reasons for FDA’s action and steps you can take to address our findings and be considered for removal from the Import Alert.

Potentially Under Processed Low-acid Canned Foods

On February 15, 2023, the Utah Department of Agriculture & Food (UDAF) collected sample 1217315 of Geisha brand medium shrimp 4 oz. (Geisha medium shrimp) lot LGC12W12E22; BEST BY: MAY/12/2026 after receiving reports of swelling, leaking, and bursting cans. In addition, after additional reports of swelling, leaking, and bursting cans, UDAF collected sample 1219196 of Geisha medium shrimp, lot LGC12W04E22; BEST BY MAY/04/2026. Both lots were manufactured at your facility and distributed in the US by (b)(4). FDA laboratory analysis of samples 1217315 and 1219196 found microbiological contamination in both lots and found anaerobic, mesophilic, gram positive rods with terminal spores in sample 1219196. Based on these findings, FDA determined that these products may have been under processed and could be contaminated with spoilage organisms or pathogens. On February 27, 2023, (b)(4) recalled lot (b)(4) and on April 21, 2023, (b)(4) recalled all lots of Geisha medium shrimp for which you were the supplier. On March 14, 2023, FDA collected sample 1218618 of Alberto brand sardines in tomato sauce lot (b)(4); EXP: 01-FEB-2026 manufactured in your facility and presented for entry into the United States. FDA laboratory analysis of sample 1218618 found facultative anaerobic gram-positive rods, again supporting that the products may have been under processed; therefore, this product was refused.

Emergency Permit Control (21 CFR 108) and Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113)

1. You must process each low-acid canned food in conformity with at least the scheduled process, as required by 21 CFR 108.35(c)(3)(i). However, during our inspection, our investigators reviewed processing records for your canned shrimp in brine and your filed scheduled process for canned shrimp in brine in size (b)(4) metal cans (SID: (b)(4)), and observed the following deviations from the filed scheduled process:

a. Your scheduled process for shrimp in brine in size (b)(4) metal cans identifies the minimum initial temperature as (b)(4)°C ((b)(4)°F). You did not meet the minimum initial temperature during the processing of “Camaron al natural” (shrimp in brine) on the following dates: May 4, 10, 12, 13, 16, 18, and 20, 2022 and July 13, 15, 19, 20, 22, 28, 2022. Your processing records show that the minimum initial temperature was between (b)(4)°C and (b)(4)°C on these dates.

We also note that your filed process identifies the processing time and temperature as (b)(4)°F for (b)(4) minutes. However, according to your processing records, your processing time was less than (b)(4) minutes ((b)(4) minutes at (b)(4)°F) on these dates. Your heat penetration study from 2018, which was filed with your scheduled process, indicates that when the minimum initial temperature is (b)(4)°F, the processing time and temperature to reach commercial sterility is (b)(4)°F for (b)(4) minutes; however, you did not have your process authority evaluate the under processed product for safety.

b. Your scheduled process for shrimp in brine size (b)(4) metal cans identifies the maximum net fill weight as (b)(4) oz. ((b)(4)g), and your heat penetration study from 2018 identifies the fill weight as (b)(4) oz. However, you exceeded the net fill weight on the following dates: May 4, 10, 12, 13, 16, 18, and 20, 2022 and July 13, 15, 19, 20, 22, 28, 2022. According to your net fill weight monitoring records, the maximum net fill weight was greater than approximately (b)(4)g for all the cans produced on those dates. In addition, you approved a minimum net fill weight product specification of (b)(4)g for this product on January 28, 2019, approximately (b)(4) months after submitting the filed scheduled process to the FDA with a maximum net fill weight of (b)(4)g.

c. Your scheduled process provides for the use of a can size of (b)(4) for canned shrimp in brine. However, you used a can size of (b)(4) on the following 13 dates: May 4, 10, 12, 13, 16, 18, and 20, 2022 and July 13, 15, 19, 20, 22, 28, 2022. In addition, you approved the can specifications for the size (b)(4) metal cans on January 28, 2019, approximately (b)(4) months after you were using the larger cans.

d. Your scheduled process for shrimp in brine size (b)(4) metal cans identifies the type of retorts as (b)(4). However, your retort operator told our investigators that your firm uses (b)(4) retorts. Your retort operator stated that they monitor the water level for the retorts, but they could not identify how the water level is monitored, and the water level was not documented on the processing records. Furthermore, our investigators did not observe a water level sight glass or any other type of water level near the retort door. The lack of a sight glass on a (b)(4) retort can lead to low water levels not being detected. Moreover, on April 10, 2023, our investigators observed that retort (b)(4) was leaking from the bottom of the retort door, which could also result in low water levels. Low water levels may cause temperature drops in the retort and lead to under processing.

On April 12, 2023, you provided our investigators with a heat penetration study and temperature distribution study for retort “(b)(4)” dated April 4, 2023, which identifies the retort as a (b)(4). These studies were completed after the (b)(4) lots of canned shrimp in brine were manufactured in 2022, and your filed scheduled process in place in 2022 identified a (b)(4) retort. Furthermore, all your filed scheduled processes for canned shrimp identify a (b)(4) retort.

Your May 12, 2023, response stated that you filed a new scheduled process in 2023 to support the product manufactured in 2022. However, you did not provide any documentation that the process had been reviewed by your process authority prior to the processing of the (b)(4) lots manufactured in 2022, as required by 21 CFR 108.35(c)(2)(ii). Further, you have not evaluated all products manufactured prior to the heat penetration study dated January 18, 2023, and the temperature distribution study dated April 4, 2023, nor have you provided an evaluation by your process authority of the (b)(4) lots of canned shrimp manufactured in 2022, as required by 21 CFR 113.89. Furthermore, pursuant to 21 CFR 108.35(c)(3)(ii) and as explained in FDA’s notifications dated January 27, 2023 and April 21, 2023, FDA cancelled the new scheduled process because of your failure to respond to an FDA inquiry regarding the process. As part of your response to this Warning Letter, you should have all the products and processes evaluated by your process authority and file new scheduled processes that are reflective of the actual operations and equipment in your facility.

In addition, we note that you have a second Food Canning Establishment number under the firm name, “Godi S:A Company” that appears to be the same facility registered as a food canning establishment under the name Gondi, S.A.; however, it does not have a valid food facility registration under section 415 of the FD&C Act (21 U.S.C. § 350(d)). You cancelled both Food Canning Establishment registrations on June 8, 2023, stating your firm is out of business, however, you have not cancelled your food facility registration. If you intend to ship LACF products to the United States, you should promptly take action to rectify these discrepancies with your required registrations as required by 21 CFR Part 1, Subpart H and 21 CFR 108.35(c)(1).

2. You must record all processing and production information at the time it was observed by the retort or processing system operator, or other designated person, as required by 21 CFR 113.100(a). You must also determine and record with sufficient frequency the initial temperature of the contents of the containers, as required by 21 CFR 113.87(c). Your operators record processing and production information on a retort operator log. On April 12, 2023, our investigators observed part of the (b)(4) cycle of tuna in can size (b)(4) in (b)(4) (retort) “(b)(4).” Venting time must be observed and recorded during this process. Your retort operator did not record the venting time, and the operator log was not in the retort area. The retort operator log was later identified on a table outside of the production room and had multiple empty data fields, including date, product name, code, lot code, and time and temperature for the sterilization program. Furthermore, information was missing from the (b)(4) cycle, including the initial temperature, total venting time and temperature, start of sterilization, and (b)(4) temperature. Your retort operator stated they complete the log after the end of the (b)(4) cycle by reviewing the temperature charts to determine the time and temperature for each event and stated that the retort is left unattended during employee breaks. You are not adequately monitoring and recording the processing and production information so that process deviations can be identified when they occur.

Your response stated that the retort operator considered the electronic data provided by the driver software and temperature charts to be sufficient to complete the manual record at the end of the (b)(4) cycle. This response is not adequate to address the violation. You must ensure all important processing information is recorded and monitored in real time to achieve commercial sterility and to identify process deviations in a timely manner.

3. You must mark each (b)(4) sealed container of low-acid processed food with an identifying code that identifies in code the establishment where packed, the product contained therein, the year packed, the day packed, and the period during which packed, as required by 21 CFR 113.60(c). The packing period code shall be changed with sufficient frequency to enable ready identification of lots during their sale and distribution. Codes may be changed on the basis of one of the following: intervals of (b)(4) hours; personnel shift changes; or batches, as long as the containers that constitute the batch do not extend over a period of more than one personnel shift. However, your operations manager indicated that your commercial lot code that is printed on a can may contain more than one production lot code, (i.e., it may represent several days of production).

Your response indicated you would make a change, but you did not provide any supporting documentation for the changes to the identifying code, nor did you provide a timeframe for which the corrective action will be implemented.

4. You must have plant personnel involved in thermal processing systems or other critical factors of the operation under the operating supervision of a person who has attended a school approved by FDA, as required by 21 CFR 108.35(g) and 21 CFR 113.10. During the inspection, our investigators requested records to show that one or more of your plant personnel have attended such a school, but you did not provide any such records.

Your response did not provide documentation demonstrating that any of your plant personnel have attended such a school or plan to attend such a school.

Products currently on the market in the U.S.

On May 11, 2023, we shared our concerns, based on the sample and inspectional findings, that all products processed in your facility for the US market may be under processed. We asked you to provide a list of your US customers and the LACF products you process for them. Further, we asked you to evaluate all LACF products that may still be available to US consumers and to take appropriate corrective actions, including a voluntary recall. You have not responded to our requests.

This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR 108 and 113). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. If you do not believe your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

In addition to the above listed violations, we provide the following comment:

As your firm is a low-acid canned food processor for seafood products, including shrimp, tuna, and sardines, you must be in compliance the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), among other requirements. Our investigators observed inadequate measures to protect food from contamination, inadequate sanitary facilities, and inadequate pest control related to the processing of your canned seafood products. Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified to advise you regarding compliance with 21 CFR Parts 108, 113, 117, and 123. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance, and that the consultant evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including processing records for five lots of product produced over at least five days. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. Responding in English will help to assist us in our review of your documentation.

Please send your reply to the Food and Drug Administration, Attention: Victoria Wagoner, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Victoria Wagoner via email at Victoria.Wagoner@fda.hhs.gov. Please reference 658698 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Ann Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition