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  5. Pure Ground Ingredients, Inc. - 639559 - 01/03/2022
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WARNING LETTER

Pure Ground Ingredients, Inc. MARCS-CMS 639559 —


Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Kevin J. Lindseth
Recipient Title
CEO
Pure Ground Ingredients, Inc.

2535 Business Parkway
Minden, NV 89423-8931
United States

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

United States

Secondary Issuing Offices

United States


WARNING LETTER

January 3, 2022

WL 639559

Dear Mr. Lindseth:

The United States Food and Drug Administration (FDA) inspected your dried herbs and spices processing facility, located at 2535 Business Parkway, Minden, NV 89423 from June 24 through July 14, 2022. Your firm imports organic dried herbs and spices and processes and/or re-packages them into bulk packaged ready-to-eat (RTE) organic dried herb and spice products. This inspection was initiated in response to a Class 1 Recall for Salmonella reported in oregano products. During our inspection of your facility, the FDA investigator 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). At the conclusion of the inspection FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your facility.

Based on FDA’s inspectional findings, we have determined that the RTE organic dried herb and spice products processed and/or packaged 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 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 on FDA’s homepage at http://www.fda.gov/.

Furthermore, your firm failed to report a reportable food to the Reportable Food Registry within twenty-four hours of becoming aware that an article of food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals, as required by Section 417(d)(1) of the Act [21 U.S.C. § 350f(d)(1)].

We received your written responses dated August 3, 2022, September 2, 2022, October 3, 2022, November 3, 2022, and December 3, 2022, which described corrective actions taken by your firm including revised procedures, training records, photographs, validation methodology, validation studies, and supporting documentation. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We also address your response below.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. You did not validate that the process preventive controls identified and implemented in accordance with 21 CFR 117.135 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility's food safety system, as required by 21 CFR 117.160(a). Specifically, your hazard analysis for RTE herbs and spices identified pathogens as a hazard requiring a preventive control at the (b)(4) step. Your firm’s Food Safety Plan SOP-403, dated 3/18/2022, listed critical limits at the “(b)(4)” preventive control of “(b)(4) for (b)(4) total in (b)(4) for (b)(4) total in (b)(4)” to control the “Microbiological” hazard. However, you did not validate that your (b)(4) Treatment preventive control is adequate to control the hazard of Salmonella in all products being treated. You processed the following products using an unvalidated (b)(4) Treatment preventive control:

  • Organic Oregano Leaf Ground and Powder lots OREO-1302392MR-GR-938J and OREO-1302392MR-PW-938J on 4/1/2022, 4/4/2022, 4/5/2022, 4/6/2022 and 4/7/2022
  • Organic Peppermint Leaf Powder lot PEPO-5232468TMRN-PW-829I on 4/17/2021 and 4/19/2021
  • Organic Spearmint Leaf Powder lot SPEO-5232468TMRN-PW-760I on 4/19/2021.

You completed an in-plant validation (Project (b)(4)) on March 30, 2020, to validate the microbial lethality of the (b)(4) system using parsley. This was the only validation completed by your firm for your (b)(4) system at the time the above referenced lots were produced. You did not have information to establish how the values for process parameters in your validation could apply to the other products being treated by the (b)(4) system.

Additionally, your validation report determined that the following parameters and values could achieve a minimum (b)(4) reduction of Salmonella in parsley: Throughput of (b)(4) kg/hr; Speed of (b)(4) (i.e., treatment time) of (b)(4) and (b)(4) temperatures of (b)(4); (b)(4) temperature of (b)(4); and (b)(4) in (b)(4) and (b)(4) of (b)(4). However, your critical limits of “(b)(4) total in (b)(4) for (b)(4) total in (b)(4)” listed at the “(b)(4)” preventive control do not match the values listed in the validation report. Specifically, the critical limits for temperature and treatment time are less than the values listed in the validation study. In addition, the critical limits do not include throughput speed, or the amount of (b)(4) added in (b)(4) and (b)(4). This is a repeat observation from FDA’s 2019 inspection, as your firm did not have a validation study for (b)(4) treatment to control for microbiological hazards in your spice products as required by 21 CFR § 117.160(a).

In your responses, you stated that you would be implementing established CCPs parameters from parsley validation including minimum treatment temperature and time. In addition, you stated that you were in the process of completing (b)(4) validation studies in which you categorized your products into (b)(4) different groups and would conduct a validation study per group based on the worst-case scenario product. Further, you indicated that, following the studies, you will revise existing procedures and develop new ones per product group to establish “final validation (b)(4) setting requirements.”

We reviewed the documents you provided in support of your corrective action for dried herbs and spices including (b)(4) Statement regarding product grouping dated July 20, 2022; (b)(4) Validation Guidelines, Evaluation of the Microbial Lethality of a (b)(4) system for Salmonella Inactivation in several Spice and Herbs products dated October 27, 2021; (b)(4) Certificate of Validation for Organic Nutmeg for Validation Trials in November 2021 and June 2022; Analytical Results for (b)(4) Treatment Settings email dated August 2, 2022; Training Record dated 08/03/2022 for Group (b)(4) Treatment Parameters and Validation Report; Evaluation of the microbial lethality of a (b)(4) system for Salmonella inactivation in (b)(4) dated July 20, 2022; Analytical Results (b)(4) and (b)(4);; Evaluation of the microbial lethality of a (b)(4) system for Salmonella inactivation in (b)(4) dated October 18, 2022; (b)(4) Certificate of Validation for Organic (b)(4) for Validation Trials in August 2022 and September 2022; Evaluation of the microbial lethality of a (b)(4) system for Salmonella inactivation in (b)(4) dated November 24, 2022; (b)(4) Certificate of Validation for Organic (b)(4) for Validation Trials in August 2022, September 2022 and November 2022; Analytical Results (b)(4); and other supporting documents. Based on our review, we have the following concerns:

  • Your Statement on Grouping states that you “categorize like products based on intrinsic properties and determine the worst-case scenario/the most conservative product to validate within each group.” You further state that your “grouping strategy has been advocated by the American Spice Trade Association.” However, the American Spice Trade Association’s (ASTA’s) guidance recommends that you first group by part of the plant and product form (e.g., ground or whole), before considering other intrinsic properties, which your firm does not appear to do (see “Guidance on Science-Based Groupings to Optimize Validation of Spice Process Controls,” pg. 6). Further, your Statement does not include consideration of water activity, which ASTA recommends as an intrinsic property to take into account throughout the groupings. Your firm’s Statement on Grouping also asserts that your science-based grouping has its basis in FDA’s “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.” However, the FDA guidance includes water activity as a common factor to consider when designing a heat treatment as a process preventive control and, as mentioned, your Statement does not include water activity as a factor to consider (see “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food,” chpt. 4, pg. 9). Additionally, you do not provide a rationale as to how you determined the worst-case scenario product within each group, and how the intrinsic properties affected your selection. We note that your validation guidelines identified (b)(4) as the worst-case scenario product in group (b)(4); however, you chose to validate parsley.
  • Your validation report “Evaluation of the microbial lethality of a (b)(4) system for Salmonella inactivation in (b)(4),” dated July 20, 2022,” stated that validation trials achieved a minimum (b)(4) reduction of Salmonella in (b)(4) using (b)(4) as a surrogate organism. However, your firm did not provide actual microbiological data in section 5.2 “Microbiological Sample Results and Log Reduction Calculation.” In addition, your validation report indicated that there were two non-compliant samples. Specifically, “(b)(4).” It is not clear how you determined that the validation was successful despite finding samples that were non-compliant. Additionally, although the validation report specifies values for temperature parameters at (b)(4), it is not clear that your firm conducted temperature monitoring during the validation.
  • Your validation report for “Evaluation of the microbial lethality of a (b)(4) system for Salmonella inactivation in (b)(4),” dated October 18, 2022, stated that “validation trials confirmed that the evaluated system can achieve, in the tested conditions, a minimum (b)(4) reduction for the surrogate microorganism and for Salmonella by correlation on organic (b)(4) and for other product of the (b)(4).” However, your firm did not provide actual microbiological data in section 5.2 “Microbiological Sample Results and Log Reduction Calculation.” In addition, you stated that the worst-case product of group (b)(4) was “identified as the organic (b)(4), which presents the lowest moisture level of the group and the highest density.” However, your validation guidelines, dated October 27, 2021, indicated that marshmallow root was selected as the worst-case product of group (b)(4). It is not clear as to why (b)(4) was not identified as the worst-case scenario product in the validation guidelines. We also noted that marshmallow root is not listed in the validation report for (b)(4) in “Table 3: Group (b)(4) product specifications.” Further, it is not clear how (b)(4) was selected as the worst-case product to perform the validation when other products, such as elder berries, have higher density and carbohydrates. Overall, your firm’s validation report for (b)(4) does not provide sufficient science-based rationale for your identification of the worst-case product and lacks microbiological data.
  • Your validation report for “Evaluation of the microbial lethality of a (b)(4) system for Salmonella inactivation in fennel,” dated November 24, 2022, concluded that “results obtained during in-plant validation trials confirmed that the evaluated system can achieve, in the tested conditions, a minimum (b)(4) reduction for the surrogate microorganism and for Salmonella by correlation on organic fennel seeds and for other products of the group (b)(4).” However, you stated that the “worst-case product of this group was identified as the organic fennel Seed (product #14), which presents the highest fat content and the highest protein content.” ASTA’s guidance states that water activity and density may have the greatest impact on the survival of Salmonella (see “Guidance on Science-Based Groupings to Optimize Validation of Spice Process Controls,” pg. 10). When selecting the representative worst-case spice, consideration should be given to the parameters of most importance to the treatment method. For example, if the product is being irradiated, then density may be the most important parameter, while water activity may be more relevant to a thermal process. Therefore, it would be appropriate to select the product with the highest density and lowest water activity as the worst-case product (see “Guidance on Science-Based Groupings to Optimize Validation of Spice Process Controls,” pg. 11). In “Table 3: Group (b)(4) product specifications” of your validation report, fennel seed is listed with the lowest density in group (b)(4) with a density of 44, while hawthorn berry has the highest density of 422 in group (b)(4). In addition, inconsistent moisture levels for fennel seed are listed in the validation report. In Table 3, which was used to select the product to validate, the moisture level of fennel seed is listed as (b)(4), while in “Table 4: Product specifications,” the fennel seed product used for validation is listed as having moisture content (pre-process) at 3.9-7.3%. It is not clear why the moisture content levels of fennel seed are different. Overall, your firm’s validation study for group (b)(4) does not provide sufficient science-based rationale for your identification of the worst-case product.

2. You did not implement your written corrective action procedures that must be taken if preventive controls are not properly implemented, as required by 21 CFR 117.150(a)(1). Specifically, your Food Safety Plan SOP-403, dated 3/18/2022, at the “(b)(4)” preventive control lists critical limits of “(b)(4) for (b)(4) total in (b)(4) for (b)(4) total in (b)(4)” to control the “Microbiological” hazard. Your Quality Manager stated the critical limit which applied to Organic Oregano Leaf Ground and Powder was not less than (b)(4) for (b)(4) total in (b)(4). You monitor this critical limit through your (b)(4) temperature/time recording system. The corrective actions listed at this preventive control are "check shows time/temp is below critical limits, product must be isolated to the last good check and tagged. Isolated product will be re-run with the corrected settings."

However, you processed Organic Oregano Leaf Ground and Powder, lots OREO-1302392MR-GR-938J and OREO-1302392MR-PW- 938J on 4/4/2022, 4/5/2022, 4/6/2022 and 4/7/2022, below the critical limits listed in your food safety plan. The data logger from your (b)(4) temperature/time recording system showed the following deviations from the temperature critical limit during the following production runs, in some instances reading between (b)(4):

  • On 4/4/2022 the temperature was less than (b)(4) in (b)(4) from 5:37 to 5:39 PM.
  • On 4/4/2022 the temperature was less than (b)(4) in (b)(4) from 5:39 to 5:40 PM.
  • On 4/5/2022 the temperature was less than (b)(4) in (b)(4) and (b)(4) from 6:46 to 7:30 PM.
  • On 4/6/2022 the temperature was less than (b)(4) in (b)(4) from 11:42 to 11:48 AM.
  • On 4/6/2022 the temperature was less than (b)(4) in (b)(4) from 11:42 to 11:50 AM.
  • On 4/7/2022 the temperature was less than (b)(4) in (b)(4) from 9:04 to 9:06 AM.
  • On 4/7/2022 the temperature was less than (b)(4) in (b)(4) from 9:07 to 9:08 AM.

Your Quality Manager stated you did not re-process these lots of Organic Oregano Leaf Ground and Powder, and you did not have any records documenting that a corrective action was taken. Further, Organic Oregano Leaf Ground lot OREO-1302392MR-GR-938J was found positive for Salmonella by a customer.

Additionally, you did not review your process preventive control monitoring records. Specifically, your firm did not review the temperature data logger information for the above-mentioned days and times. Further, your firm’s (b)(4) Monitoring forms did not document the above-mentioned critical limit deviations, and your review of these records did not note that a critical limit deviation occurred. This is a repeat observation from FDA’s 2019 inspection. During the 2019 inspection our investigators found your firm did not take corrective actions when the critical limits for time and/or temperature to control for microbiological hazards were not met during (b)(4) of organic whole fennel seed lot FENO-5041847Z-WH-024F, and organic whole nettle leaf lot NELO-1721918Z-WH-025F. Additionally, you had to recall fennel seed tea cut lot FENO-5041847Z-TC-126F because the product was found positive for Salmonella by one of your customers. Our investigators noted that during your root cause analysis, you found that the (b)(4) did not reach the critical limits.

You indicated in your written responses that you are implementing a review of your monitoring records, including review of the data logger (recording system). You also explained that all of your operators underwent (b)(4) of verbal and hands-on training on the (b)(4) instrument, including process treatment monitoring and corrective actions for any deviations, and that the (b)(4) Platform will provide conformity certificates validating that each production run achieves the required critical limits. You stated that you have implemented your “Treatment data logger verification” and “Treatment corrective action records documentation and monitoring form.” You also provided an example of a “Treatment Conformity Certificate (Pass/Fail).” However, you did not provide documentation to demonstrate that the data logger records and the “(b)(4) Observation Log” are currently being reviewed following each production run.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

1. Your equipment and utensils were not designed and were not of such material and workmanship as to be adequately cleanable, and were not adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1). Specifically, on 6/29/2022, the FDA investigator observed that the exterior surface of the hopper located in the upper level of (b)(4), used for loading product into the (b)(4) milling equipment, appeared to have rough welds and was not maintained with a smooth surface. In addition, the metal appeared to be separated in the corner of the hopper.

You stated in your written responses that the hopper was repaired, and the welds smoothed out. The photographs provided are close-up, and therefore we are not able to evaluate if the entire hopper was repaired. The effectiveness of your repairs will be evaluated during the next inspection.

Reportable Food Registry (21 CFR Part 417)

1. You failed to report a reportable food to the Reportable Food Registry, in violation of section 417 of the Act [21 U.S.C. 350f]. The Reportable Food Registry was established by section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085) to provide a reliable mechanism to track patterns of adulteration in food in order to support FDA efforts to target limited inspection resources for the protection of public health. The regulation requires a responsible party to file a report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals (see section 417(d)(1)(A) of the Act). Such foods are “Reportable Foods,” under section 417(a)(2) of the Act. The responsible party is the person who submits the registration under section 415(a) of the Act for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held. Failure to submit a required report about a reportable food is a prohibited act under Section 301(mm) of the Act [21 U.S.C. § 331(mm)].

Your firm failed to report two shipments containing reportable food to the Reportable Food Registry. Specifically,

  • You received a shipment of (b)(4) bags, each bag weighing (b)(4), of raw material organic peppermint leaf, (b)(4), from your (b)(4) supplier on 4/7/2021. You had this lot of organic peppermint leaf tested by a private laboratory and the Certificate of Analysis (report (b)(4)) dated 4/14/2021 showed that the raw material lot was positive for Salmonella.
  • You received a shipment of (b)(4) bags, each bag weighing (b)(4), of raw material organic spearmint leaf, (b)(4), from your (b)(4) supplier on 4/7/2021. You had this lot of organic spearmint leaf tested by a private laboratory and the Certificate of Analysis (report (b)(4)) dated 4/15/2021 showed that the raw material lot was positive for Salmonella.

On August 15, 2022 you informed FDA that you had processed (i.e., reconditioned) these lots of raw products based on the in-plant validation (Project (b)(4)) conducted on March 30, 2020, validating the microbial lethality of the (b)(4) system using parsley. Additionally, you stated in your written responses that you investigated the reconditioned food products to determine whether they were reportable foods. However, you did not file a Reportable Food Registry Report with FDA when your firm became aware of the Salmonella positives in these raw materials, and as already noted above in this letter, you have not demonstrated that you have adequately validated your (b)(4) Treatment. These products were distributed as finished product lots PEPO-5232468TMRN-PW-829I and SPEO-5232468TMRN-PW-760I, respectively.

This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502

Refer to Unique Identification Number CMS# 639559 when replying.

If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.

If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.

Sincerely,
/S/

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

 
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