It is interesting in that the company stated in the hazard analysis that although Vitamin D was identified as a hazard in the formulation, it would be controlled through prerequisite programs. This of course failed with high Vitamin D levels getting into their premix and thus their customer's finished product and then finally that product impacting dogs.
Another interesting point to note is that the responses provided by the company to FDA were viewed as inadequate. Although the company stated that they took corrective action after the incident, including making hazardous ingredient addition a preventive control, they did not provide FDA sufficient documentation for the control of their process. The FDA response states, the company "did not provide sufficient supporting documentation, such as revised standard operating procedures, test results, or other documentation, to show that you have implemented these proposed corrective actions. For example, your supporting documentation for (b)(4) reconciliation includes only the record of a (b)(4) reconciliation on June 21, 2019. We are unable to determine the adequacy of relabeling, (b)(4), and (b)(4) at controlling the hazard because the batches with elevated levels of vitamin D occurred despite a (b)(4) process and (b)(4). With respect to your preventive control, you have identified (b)(4) per lot as the allowable variance for your process control. It is unclear whether that variance would ensure that vitamin levels would result in an animal food for which nutrient toxicity or deficiency is controlled. FDA will verify the adequacy of your corrective actions during the next inspection of your firm."
Warning Letter
DSM Nutritional Products, LLC
MARCS-CMS 578300 — October 11, 2019 Recipient:
Chris Goppelsroeder
President
DSM Nutritional Products, LLC
45 Waterview Blvd.
Parsippany, NJ 07054
United States
Issuing Office:Division of Human and Animal Food Operations West III
4040 North Central Expressway, Suite 300
Dallas, TX 75204-3128
United States
October 11, 2019
CMS # 578300
WARNING LETTER
Dear Mr. Goppelsroeder:
The U.S. Food and Drug Administration (FDA) along with the Office of the Texas State Chemist (OTSC), under Federal contract, inspected your vitamin and mineral premix animal food manufacturing facility located at 5101 Rondo Dr., Fort Worth, TX 76106 on February 6, 2019 and February 7, 2019. This inspection was conducted as a follow-up to a Reportable Food Registry event ((b)(4)) in which elevated levels of vitamin D3 were identified in vitamin and mineral premixes manufactured in your facility. This Reportable Food Registry event was discovered after your customer received consumer complaints and determined that there were elevated levels of vitamin D in their finished dog food produced using your premix ingredients.
The inspection revealed violations of FDA’s hazard analysis and risk-based preventive controls requirements for animal food, which cause your products to be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act).1 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under the FD&C Act.2 Furthermore, the failure to follow the hazard analysis and risk-based preventive controls requirements is also a prohibited act under the FD&C Act.3 You may find the Federal Food, Drug, and Cosmetic Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We received your written response to those observations, dated February 26, 2019. Additionally, on April 17, 2019, your firm attended a regulatory meeting with FDA’s Office of Human and Animal Food Operations West 3, FDA’s Center for Veterinary Medicine, and OTSC in which you provided additional details of your firm’s corrective actions. On May 23, 2019, and July 11, 2019, we received additional information regarding the implementation of your firm’s corrective actions to date. We have reviewed your responses, and we discuss your significant violations and your corrective actions below.
Adulterated Animal Food
During our inspection of your facility, Investigators noted violations of the Hazard Analysis and Risk-Based Preventive Controls requirements for animal food found in Title 21 Code of Federal Regulations part 507, subpart C (21 CFR part 507, subpart C). These violations render your animal food products adulterated under the FD&C Act.4 Violations observed during the inspection include, but are not limited to, the following:
1. Your firm did not sufficiently assess the probability that a vitamin D toxicity hazard will occur in the absence of a preventive control as required by 21 CFR 507.33(c)(1). Specifically, you identified vitamin D toxicity as a known or reasonably foreseeable hazard in your hazard analysis, and you stated that “[o]ver dosage of vitamin D is considered a risk for dogs”. In your hazard evaluation, you determined that the probability of occurrence for this hazard was reduced due to your reliance on prerequisite programs. However, as evidenced by your and your customer’s findings of elevated levels of vitamin D in your premixes, your prerequisite programs were either insufficient or you failed to implement them adequately to ensure the inclusion of vitamin D did not result in a nutrient toxicity.
Specifically, on January 22, 2019, your firm received a complaint from your customer of elevated levels of vitamin D3 in their product. As a result, your firm obtained analytical results of your facility’s retained samples of suspected product and compared these levels to the claimed amount. These analytical results revealed two (2) batches of vitamin premix that were determined to be manufactured on August 16, 2018 and contained levels of vitamin D3 in excess of the amount intended:
• 2217 Canned Canine PMX; Product Code: NP15268025; Batch: 9100058130 contained vitamin D levels at 2903% of the amount claimed.
• 2217 Canned Canine PMX; Product Code; NP15268025, Batch: 9100058131 at 307% of the amount claimed.
Your investigation revealed that the batch with vitamin D levels at approximately 2900% of the intended potency was the result of human operator error in your blending process because of the similar appearance of the cardboard cylinder storage drums for vitamin D and vitamin E, as well as a failure of human secondary review at the site. Furthermore, since your firm does not have a clean-out step between batches, the following batch had residual concentrated vitamin D, which resulted in vitamin D levels at approximately 300% of the intended potency. Additionally, at the time these batches were made, your firm had no procedure to make you aware of the ingredient use deviations. Your firm adopted policies for (b)(4) counts of key ingredients ((b)(4)) immediately after your investigation and before the FDA inspection.
Vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus. However, when high levels of vitamin D are consumed, excessive vitamin D is not excreted but stored in fat tissue and the liver. The adverse health consequences from consuming excessive levels of vitamin D can lead to kidney failure and even death.5 The batches of nutrient premix with elevated levels of vitamin D were sold and shipped to your customer who used the nutrient premix in the manufacturing of canned dog food at their typical rate of inclusion. The finished canned dog food was shipped to retailers and sold to customers who fed the canned dog food to their pets. Your customer’s products have been implicated in multiple consumer complaints of ill and deceased dogs.
In your responses to the Form FDA 483, you state that your firm has implemented a (b)(4) reconciliation of key ingredients (vitamins (b)(4)); developed and implemented a “Process Flow – (b)(4)” program; relabeled and reorganized your ingredient receiving area and implemented a (b)(4) review of batch staging and production documentation to help ensure the correct ingredients are used in each batch; changed to a (b)(4) that is (b)(4) from the (b)(4); added (b)(4) to your critical ingredients, including vitamin D; conducted a reanalysis of your hazard evaluation; and added a preventive control of a (b)(4) count of vitamin (b)(4) sources to control the hazard of nutrient deficiencies and toxicities.
We are unable to evaluate your proposed corrective actions because you did not provide sufficient supporting documentation, such as revised standard operating procedures, test results, or other documentation, to show that you have implemented these proposed corrective actions. For example, your supporting documentation for (b)(4) reconciliation includes only the record of a (b)(4) reconciliation on June 21, 2019. We are unable to determine the adequacy of relabeling, (b)(4), and (b)(4) at controlling the hazard because the batches with elevated levels of vitamin D occurred despite a (b)(4) process and (b)(4). With respect to your preventive control, you have identified (b)(4) per lot as the allowable variance for your process control. It is unclear whether that variance would ensure that vitamin levels would result in an animal food for which nutrient toxicity or deficiency is controlled. FDA will verify the adequacy of your corrective actions during the next inspection of your firm.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
We have the following comments:
• We note that your firm provided copies of specifications for both the Rovimix E 50-SD (vitamin E) and Rovimix D3-500 (vitamin D) during the inspection. The specifications establish limits for color of each ingredient: “(b)(4)” for the E 50-SD, and “(b)(4)” for the D3-500. If the ingredients are visually different, as suggested by the specifications, then there is a potential to control substitution of ingredients by recognizing the visual difference between ingredients while introducing them to the mixing system.
• Any preventive control that you have established is subject to preventive control management components, as required by 21 CFR 507.39.
• For more information on the Current Good Manufacturing Practice requirements of 21 CFR part 507, subpart B please see FDA’s Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf.
• For more information on the Hazard Analysis and Risk-based Preventive Controls requirements of 21 CFR part 507, subparts C and E please see FDA’s draft Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM592870.pdf.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time frame within which you will complete the correction. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Section 743 of the FD&C 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 reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the FD&C 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 non-compliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at chad.whitwell@fda.hhs.gov or 214-253-5328.
MARCS-CMS 578300 — October 11, 2019 Recipient:
Chris Goppelsroeder
President
DSM Nutritional Products, LLC
45 Waterview Blvd.
Parsippany, NJ 07054
United States
Issuing Office:Division of Human and Animal Food Operations West III
4040 North Central Expressway, Suite 300
Dallas, TX 75204-3128
United States
October 11, 2019
CMS # 578300
WARNING LETTER
Dear Mr. Goppelsroeder:
The U.S. Food and Drug Administration (FDA) along with the Office of the Texas State Chemist (OTSC), under Federal contract, inspected your vitamin and mineral premix animal food manufacturing facility located at 5101 Rondo Dr., Fort Worth, TX 76106 on February 6, 2019 and February 7, 2019. This inspection was conducted as a follow-up to a Reportable Food Registry event ((b)(4)) in which elevated levels of vitamin D3 were identified in vitamin and mineral premixes manufactured in your facility. This Reportable Food Registry event was discovered after your customer received consumer complaints and determined that there were elevated levels of vitamin D in their finished dog food produced using your premix ingredients.
The inspection revealed violations of FDA’s hazard analysis and risk-based preventive controls requirements for animal food, which cause your products to be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act).1 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under the FD&C Act.2 Furthermore, the failure to follow the hazard analysis and risk-based preventive controls requirements is also a prohibited act under the FD&C Act.3 You may find the Federal Food, Drug, and Cosmetic Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We received your written response to those observations, dated February 26, 2019. Additionally, on April 17, 2019, your firm attended a regulatory meeting with FDA’s Office of Human and Animal Food Operations West 3, FDA’s Center for Veterinary Medicine, and OTSC in which you provided additional details of your firm’s corrective actions. On May 23, 2019, and July 11, 2019, we received additional information regarding the implementation of your firm’s corrective actions to date. We have reviewed your responses, and we discuss your significant violations and your corrective actions below.
Adulterated Animal Food
During our inspection of your facility, Investigators noted violations of the Hazard Analysis and Risk-Based Preventive Controls requirements for animal food found in Title 21 Code of Federal Regulations part 507, subpart C (21 CFR part 507, subpart C). These violations render your animal food products adulterated under the FD&C Act.4 Violations observed during the inspection include, but are not limited to, the following:
1. Your firm did not sufficiently assess the probability that a vitamin D toxicity hazard will occur in the absence of a preventive control as required by 21 CFR 507.33(c)(1). Specifically, you identified vitamin D toxicity as a known or reasonably foreseeable hazard in your hazard analysis, and you stated that “[o]ver dosage of vitamin D is considered a risk for dogs”. In your hazard evaluation, you determined that the probability of occurrence for this hazard was reduced due to your reliance on prerequisite programs. However, as evidenced by your and your customer’s findings of elevated levels of vitamin D in your premixes, your prerequisite programs were either insufficient or you failed to implement them adequately to ensure the inclusion of vitamin D did not result in a nutrient toxicity.
Specifically, on January 22, 2019, your firm received a complaint from your customer of elevated levels of vitamin D3 in their product. As a result, your firm obtained analytical results of your facility’s retained samples of suspected product and compared these levels to the claimed amount. These analytical results revealed two (2) batches of vitamin premix that were determined to be manufactured on August 16, 2018 and contained levels of vitamin D3 in excess of the amount intended:
• 2217 Canned Canine PMX; Product Code: NP15268025; Batch: 9100058130 contained vitamin D levels at 2903% of the amount claimed.
• 2217 Canned Canine PMX; Product Code; NP15268025, Batch: 9100058131 at 307% of the amount claimed.
Your investigation revealed that the batch with vitamin D levels at approximately 2900% of the intended potency was the result of human operator error in your blending process because of the similar appearance of the cardboard cylinder storage drums for vitamin D and vitamin E, as well as a failure of human secondary review at the site. Furthermore, since your firm does not have a clean-out step between batches, the following batch had residual concentrated vitamin D, which resulted in vitamin D levels at approximately 300% of the intended potency. Additionally, at the time these batches were made, your firm had no procedure to make you aware of the ingredient use deviations. Your firm adopted policies for (b)(4) counts of key ingredients ((b)(4)) immediately after your investigation and before the FDA inspection.
Vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus. However, when high levels of vitamin D are consumed, excessive vitamin D is not excreted but stored in fat tissue and the liver. The adverse health consequences from consuming excessive levels of vitamin D can lead to kidney failure and even death.5 The batches of nutrient premix with elevated levels of vitamin D were sold and shipped to your customer who used the nutrient premix in the manufacturing of canned dog food at their typical rate of inclusion. The finished canned dog food was shipped to retailers and sold to customers who fed the canned dog food to their pets. Your customer’s products have been implicated in multiple consumer complaints of ill and deceased dogs.
In your responses to the Form FDA 483, you state that your firm has implemented a (b)(4) reconciliation of key ingredients (vitamins (b)(4)); developed and implemented a “Process Flow – (b)(4)” program; relabeled and reorganized your ingredient receiving area and implemented a (b)(4) review of batch staging and production documentation to help ensure the correct ingredients are used in each batch; changed to a (b)(4) that is (b)(4) from the (b)(4); added (b)(4) to your critical ingredients, including vitamin D; conducted a reanalysis of your hazard evaluation; and added a preventive control of a (b)(4) count of vitamin (b)(4) sources to control the hazard of nutrient deficiencies and toxicities.
We are unable to evaluate your proposed corrective actions because you did not provide sufficient supporting documentation, such as revised standard operating procedures, test results, or other documentation, to show that you have implemented these proposed corrective actions. For example, your supporting documentation for (b)(4) reconciliation includes only the record of a (b)(4) reconciliation on June 21, 2019. We are unable to determine the adequacy of relabeling, (b)(4), and (b)(4) at controlling the hazard because the batches with elevated levels of vitamin D occurred despite a (b)(4) process and (b)(4). With respect to your preventive control, you have identified (b)(4) per lot as the allowable variance for your process control. It is unclear whether that variance would ensure that vitamin levels would result in an animal food for which nutrient toxicity or deficiency is controlled. FDA will verify the adequacy of your corrective actions during the next inspection of your firm.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
We have the following comments:
• We note that your firm provided copies of specifications for both the Rovimix E 50-SD (vitamin E) and Rovimix D3-500 (vitamin D) during the inspection. The specifications establish limits for color of each ingredient: “(b)(4)” for the E 50-SD, and “(b)(4)” for the D3-500. If the ingredients are visually different, as suggested by the specifications, then there is a potential to control substitution of ingredients by recognizing the visual difference between ingredients while introducing them to the mixing system.
• Any preventive control that you have established is subject to preventive control management components, as required by 21 CFR 507.39.
• For more information on the Current Good Manufacturing Practice requirements of 21 CFR part 507, subpart B please see FDA’s Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf.
• For more information on the Hazard Analysis and Risk-based Preventive Controls requirements of 21 CFR part 507, subparts C and E please see FDA’s draft Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM592870.pdf.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time frame within which you will complete the correction. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Section 743 of the FD&C 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 reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the FD&C 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 non-compliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at chad.whitwell@fda.hhs.gov or 214-253-5328.
Sincerely,
/S/
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
Cc: Stephen J. Gristina, Director of Premix Operations – North America
DSM Nutritional Products, North America
45 Waterview Blvd.
Parsippany, NJ 07054
Lance Collard, Plant Manager
DSM Nutritional Products, LLC
5101 Rondo Drive
Fort Worth, TX 76106
.
/S/
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
Cc: Stephen J. Gristina, Director of Premix Operations – North America
DSM Nutritional Products, North America
45 Waterview Blvd.
Parsippany, NJ 07054
Lance Collard, Plant Manager
DSM Nutritional Products, LLC
5101 Rondo Drive
Fort Worth, TX 76106
.
Office of Texas State Chemists
Dr. Timothy Herrman
445 Agronomy Road
College Station, TX 77843
Dr. Timothy Herrman
445 Agronomy Road
College Station, TX 77843
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