Inspections, Compliance, Enforcement, and Criminal Investigations

Cache Commodities Incorporated 3/23/18

 

  

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March 23, 2018
 
 
WARNING LETTER
 
 
 
Via UPS Overnight
 
 
Ref: # HAF4W(DEN)-18-07-WL
 
 
Rodney B. Curtis, President
Cache Commodities Incorporated
860 W 24th ST
Ogden, UT 84401-1231
 
Dear Mr. Curtis:
 
The U.S. Food and Drug Administration (FDA) concluded our most recent inspection of your commercial feed mill located at 860 W 24th Street, Ogden, Utah on December 14, 2017. This inspection was conducted as a follow-up to a regulatory meeting held with representatives of your firm on June 9, 2017, and to investigate the death of a large number of pheasant chicks diagnosed with rickets during the spring of 2017. The pheasant chicks had consumed your Gamebird Starter Medicated (product number CA025) which was deficient in vitamin D, calcium, and phosphorus. (b)(3)(A)
 
The June 2017 regulatory meeting was held in follow-up to an inspection that concluded November 18, 2016, which investigated a complaint of the death of several hundred rabbits diagnosed with vitamin D toxicity after they consumed your Commercial Rabbit Feed, Family Rabbit Feed, and Jensen Custom Mix rabbit feed. These feeds were found to contain excessive levels of vitamin D.
 
Our inspection found numerous violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for animal food, which cause your products to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).
 
Our inspection also found numerous violations of our CGMP requirements for medicated feed, which cause your medicated feed products to be adulterated within the meaning of section 501(a)(2)(B) of the Act.
 
We also performed laboratory analysis of samples of your Gamebird Starter Medicated and Halter Power Finisher Medicated products. Our analysis demonstrated that these products are adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act.
 
In addition, we reviewed the labeling for your Amino Pro Layer Crumble and compared your labeling to our laboratory analysis of a sample of this product. Based on our review and laboratory analysis, we have determined that this product is misbranded within the meaning of section 403(a)(1) of the Act.
 
Our inspector issued a Form FDA 483 after the inspection and discussed his observations with you. On January 4, 2018, your firm sent a letter outlining your responses to our investigator’s observations. We address your responses below.
 
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. Medicated feed CGMP requirements are in title 21, Code of Federal Regulations (21 CFR), part 225. Animal food CGMP requirements are in 21 CFR part 507, subpart B, with related requirements in 21 CFR 507.4 and 21 CFR part 507, subpart F. In addition, guidance on the animal food CGMP requirements can be found in CVM GFI # 235 Current Good Manufacturing Practice Requirements for Food for Animals.
 
Your significant violations are as follows:
 
Misbranded Animal Food
 
During our 2017 inspection, we collected a sample of your product Amino Pro Layer Crumble 18% for nutrient analysis. We found this product to be outside the label guarantees for phosphorous, sodium and calcium. Specifically, the analyses found:
  • phosphorous at 0.48%, which is 69% of the 0.70% label guarantee;
  • sodium at 0.50% which is 167% of the maximum limit in the 0.10%-0.30% label guarantee; and
  • calcium at 6.61%, which is 144% of the maximum limit in the 3.10%-4.60% label guarantee.
The labeling for Amino Pro Layer Crumble is false and misleading because it does not accurately describe the amount of the mineral nutrients in this food. Thus, this food is misbranded under the Act.[1]
 
Adulterated Medicated Feed
We collected samples of two medicated feeds for drug analysis. We collected 20 sub-samples of one lot of Gamebird Starter Medicated. This product is labeled to contain 0.0175% (175 parts per million or ppm) amprolium. In a composite of 10 sub-samples we found 104 ppm amprolium, which is 59.4% of the amount declared on the label. We analyzed five additional sub-samples individually and found 92.5 ppm (52.9%), 109.7 ppm (62.7%), 107.6 ppm (61.5%), 94.4 ppm (52.9%) and 107.4 ppm (61.4%) in these sub-samples. The permissible assay limit for amprolium is 80 – 120%. So, both the composite of 10 sub-samples and each of the five additional sub-samples are outside of the permissible assay limit for amprolium. 
 
We also collected 20 subsamples of one lot of Halter Power Finisher Medicated. This product is labeled to contain 30 g/ton of monensin. In a composite of 10 sub-samples we found 14.2 g/ton monensin, which is 47.3% of the declared amount. We analyzed five more individual sub-samples and found 8.9 g/ton (29.6% ), 18.8 g/ton (62.8% ), 13. 7 g/ton ( 45.8% ), 25.1 g/ton (83. 7%) and 23.1 g/ton (77.0%) in these subsamples. The permissible assay limits for monensin in cattle feed is 85 - 115%. So, both the composite of 10 sub-samples and each of the five individual sub-samples are outside of the permissible assay limit for monensin in cattle feed.
 
As a result, your Gamebird Starter Medicated and Halter Power Finisher Medicated feed products are unsafe because they contain a subpotent drug level that does not conform with the respective approvals of the relevant new animal drug applications.[2] Medicated feeds that are unsafe under the Act[3] are adulterated under the Act.[4] 
 
In addition, the labeling for Gamebird Starter Medicated does not conform to the approved representative (“Blue Bird”) labeling for amprolium-medicated pheasant feed. For example, the drug amount on your labeling incorrectly guarantees the drug in units of percent per ton (%/ton) instead of percent (%). Your labeling does not reflect the correct intended uses (diseases) that are set forth in the new animal drug approval for amprolium-medicated pheasant feed. Specifically, the indications for use on your labeling are for use of amprolium in calves, and the caution statement includes the caution language required for calves instead of the correct indications for use, feeding directions and caution statements required when this drug is fed to pheasants. Therefore, this medicated feed is unsafe and adulterated because the labeling does not conform to the approved new animal drug application.[5] https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/BlueBirdLabels/.   It is your responsibility to ensure the medicated feed labeling you use conforms with the approved representative labeling. Representative “Blue Bird labels” for new animal drugs approved to be used in or on animal feed can be found online at
 
Animal Food Current Good Manufacturing Practice (CGMP) Violations
 
1.    Your firm failed to handle raw materials and other ingredients under conditions that will protect against contamination and minimize deterioration. (21 CFR 507.25(b)(1)). 
 
Specifically, our investigator observed multiple bags and tubs of ingredients open and spilling onto the ground or other ingredient containers in the micro ingredient shed. He also observed bags of ingredients covered in so much dust or other ingredients that their labels were difficult to read. Spilled beet pulp located in Shed 1 was partially covering a pallet of unknown ingredient bags. Some of the ingredient bags were open and their contents were intermixed with beet pulp. He observed bulk cottonseed overflowing and spilling under an overhead door in the main milling building. The door was in a state of disrepair. The poor storage conditions of the raw ingredients, including the cottonseed, are repeat observations from the 2016 FDA inspection. 
 
Your January 4, 2018 response indicates that you have cleaned up the spilled beet pulp and cottonseed, that you have erected a new inside wall to prevent the cottonseed from flowing outside of the building, and that you expect to have a solution to the beet pulp spillage problem by April 30, 2018, and that you have taken other steps to control dust within the plant. As mentioned above, this is a repeat observation from the 2016 inspection, and your letter of December 6, 2016 suggested that you were planning to address them at that time. We will evaluate these changes at our next inspection.
 
2.    You failed to keep your plant’s buildings, structures, fixtures and other physical facilities clean and in good repair to prevent animal food from becoming adulterated. (21 CFR 507.19(a)).
 
Specifically, our investigator observed multiple walls, ceilings, and overhead doors to be in a state of disrepair. He observed insulation to be deteriorating and hanging from the ceiling over raw ingredients and finished animal food. A mixture of spilled corn, other ingredients, and water from a leaking (b)(4) had formed a paste on the floor of the processing area. The outside of (b)(4) molasses (b)(4) were covered with molasses and overflowing onto the ground where it had pooled. Our investigator found (human) snack food and beverage containers and wrappers discarded throughout the facility. Many of these were repeat observations from July 2017.  
 
Your January 4, 2018 response indicates that you are fixing the insulation problem, and expect that to be resolved by January 31, 2018, and that you have already taken several steps (new (b)(4), valves, fans and (b)(4)) to control the (b)(4) within your plant, and we have already discussed construction that you have already started, or are planning. We will evaluate your progress at our next inspection. 
 
3.    You failed to keep the grounds around your animal food plant in a condition that will protect against contamination of animal food. (21 CFR 507.17(a)). You failed to properly store equipment, remove litter and waste, and cut weeds or grass that may constitute an attractant, breeding place, or harborage for pests. (21 CFR 507.17(a)(1)).
 
Specifically, our investigator observed piles of trash and debris, old equipment parts and tires, overgrown vegetation, piles of old animal food ingredients, open buckets of oil, multiple pallets and totes of expired animal food which were punctured or torn open and spilling their contents, stored throughout the grounds of your facility. These conditions have the potential to contaminate animal food ingredients and finished products, as well as serving to attract and harbor pests. During the June 2017, Regulatory Meeting, your representatives indicated that you had hired a groundskeeper to maintain your facility, although by the conclusion of our inspection in December 2017, our investigator noted that you no longer employ a groundskeeper. 
 
Your January 4, 2018 response indicates that you are in the process of cleaning the grounds, including disposal of old, recalled animal food products, and engaging an auto salvage company to remove old equipment, and you mention examples of how you plan to change your management of waste materials. We will evaluate your progress at our next inspection.
 
4.    You failed to take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against contamination of animal food by pests. (21 CFR 507.19(e)).
 
Specifically, our investigator observed a dead raccoon and live cats in the main milling building, and birds were observed flying and perching in the micro shed. He observed animal tracks and apparent raccoon, cat, bird, and rodent droppings and urine throughout the entire facility, including in spilled corn and around and on finished bagged animal food, totes of finished animal food, micro ingredient tubs, and bags of ingredients. 
 
Your January 4, 2018 response indicates that you believe some of the construction and building repair, including repairs to the broken doors and a thorough cleaning will help resolve this issue. We note that similar commitments were made in your December 6, 2016 response to our 2016 inspection, and that the corrections promised at that time have not been implemented, or have not remained in place. We will evaluate your progress at our next inspection.
 
5.    You failed to hold animal food held for distribution under conditions that will protect against contamination and minimize deterioration. (21 CFR 507.27(a)).
 
Specifically, our investigator observed throughout the facility that multiple (b)(4)(totes) and bags of finished animal food were open with their contents exposed to the environment. (b)(4) were stored directly under fiberglass insulation that is deteriorating and falling from the ceiling. Large and small pieces of this insulation were observed on the shelving and ground around the (b)(4), as well as in and around the openings to some the (b)(4). Some of the (b)(4) and bags were torn with their contents spilling onto the ground and other bags of feed. This is a repeat observation from the 2016 FDA inspection.  
 
Your January 4, 2018 response indicates, that in addition to cleaning, removal of the deteriorating insulation, and other changes already discussed, you are planning on doing additional employee training during February 2018. We will evaluate your progress at our next inspection.
 
Your response outlines several detailed changes in employee practices and training being implemented, identifies significant construction and repairs you plan to do, and suggests significant cleaning has already been done. If your plans are properly implemented, these actions may address several of the observations found during the inspection. However, similar commitments were made in your December 6, 2016 letter responding to the Form FDA 483 issued at the end of the 2016 inspection, as well as at the June 9, 2017 regulatory meeting. Some of the commitments you made in response to that inspection, or during our 2017 inspection, were either never implemented or had been implemented at one time, but were no longer being maintained. Because you did not submit any documented evidence of these remedial actions being implemented, such as photographs or copies of new procedures, we are unable to evaluate your response. We will evaluate the adequacy of these proposed changes at our next inspection. 
 
Medicated Feed CGMP Violations
 
As explained in Guidance for Industry #235 (pp. 10-11), if a facility is subject to both 21 CFR part 225 and 21 CFR part 507, subpart B, and the CGMP requirements overlap, the facility must follow the more specific requirements of 21 CFR part 507. However, since your facility is manufacturing medicated feed in addition to non-medicated feed you must also follow the specific requirements in 21 CFR part 225 related to the use of drugs in the manufacture of medicated animal feed. Your part 225 violations include:
 
1.  You failed to establish and maintain adequate procedures for the identification, storage, and inventory control (receipt and use) of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds to aid in assuring the identity, strength, quality and purity of these drug sources. (21 CFR 225.142).
 
Your batching and mixing operations are not adequate to ensure that your medicated feed products consistently contain the right amount of medication, as specified by your formulas and product labeling. Your medicated feed products are manufactured using a (b)(4), and personnel are adding ingredients to the mixer by using a (b)(4) while the (b)(4) operator is watching a running scale. This may be adequate in some cases and for some types of medicated feed, but our investigator was told that employees do not always weigh the drug into each batch – sometimes they “eyeball” the amount of medicated article being added to medicated feed products, with the effect being that you are estimating rather than measuring the amount of medication that is being added to your medicated feed products. 
 
Further, you do not record the actual amount of medication added to your medicated feed products. Rather, the operator makes a check-mark on the formula check-off sheet, indicating that the medication was added. This record also serves as the production record. (21 CFR 225.202)  These types of practices do not ensure that medicated feeds can be consistently manufactured according to established formulas and matching approved labeling. 
 
Your January 4, 2018 response to the Form FDA 483 indicates that you have implemented a new position of “FDA compliance director” within your company, that you have done some retraining with your employees regarding the need to weigh all drugs, and that you have initiated an assay program. We will evaluate these changes at our next inspection.
 
2.  You failed to identify and store bulk Type A medicated articles and bulk Type B medicated feeds in a manner such that their identity, strength, quality, and purity will be maintained. (21 CFR 225.142).
 
Specifically, our investigator observed several sources of medication that were ripped open, spilled on the floor, and covered in dust making the labels difficult to read. During the June 2017 FDA Regulatory Meeting, your representatives inquired as to how open bags of medicated articles should be properly stored, and this was discussed. Your representatives indicated that an enclosed medication room would be built to ensure proper maintenance and storage of the medication sources. Construction was expected to be completed by September 1, 2017; however, as of the close of this inspection in
 
December 2017, the enclosed room had not been constructed.
 
Your January 4, 2018 response indicates that you have purchased new (b)(4) totes in which to place open bags of the individual medications, new scoops (b)(4), and that employees have been trained on the new procedures. We note that similar commitments were made in your December 6, 2016 response to our 2016 inspection, and that the corrections promised at that time had not been implemented, or had not remained in place. We will evaluate your progress at our next inspection.
 
The above is not intended as an all-inclusive list of violations. As a manufacturer of animal food and medicated feed, you are responsible for ensuring your overall operations and the animal food and medicated feed you manufacture and distribute are in compliance with the Act and its implementing 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 injunction.
 
In addition to the violations listed above, we have the following comment about your progress in achieving voluntary compliance and producing safe animal food. Our investigator generally observed that your facility’s practices for holding raw ingredients, formulating, weighing, mixing, and holding finished animal food are not sufficient to ensure the production of safe animal food. Our investigator received a similar impression of conditions at your facility during our 2016 inspection, which resulted in a Form FDA 483 being issued to you. In a June 2017, regulatory meeting, your firm promised to take various remedial actions. These actions have not been implemented or have been implemented only temporarily. In addition, your food has been linked to the deaths of numerous animals on at least two separate occasions. You should be aware that as management of the establishment, it is your responsibility to ensure that all operations in the manufacturing, processing, packing, and holding of animal food are conducted in accordance with the CGMP requirements of 21 CFR part 507, subpart B. (21 CFR 507.25(a)(1)).
 
Please note that your firm will be required to comply with the hazard analysis and risk-based preventive controls requirements by September 17, 2018 (21 CFR part 507, subparts C and E, with related requirements in 21 CFR 507.4 and 21 CFR part 507, subpart F). Specifically, you will need to prepare a food safety plan and conduct a hazard analysis to identify known or reasonably foreseeable hazards associated with each type of animal food you manufacture. You will then need to perform a hazard evaluation to determine if you must implement preventive controls to ensure that any hazards requiring a preventive control will be significantly minimized or prevented. 
 
You should respond in writing within fifteen (15) business days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these violations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections (including how you intend to address systemic problems) your firm has taken. If your firm’s planned corrections will occur over time, please include a timetable for implementation of those activities. If corrections cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.
 
Your written response should be sent to Hanna L. Potter, Compliance Officer, U.S. Food and Drug Administration, 6th Ave & Kilpling St, DFC - Bldg. 20, P.O. Box 25087, Denver, Colorado,
 
80225-0087. You may reach Ms. Potter at (303) 236-3094 if you have any questions about this letter.
 
Sincerely,
/S/ 
LaTonya M. Mitchell
Denver District Director
Program Division Director
Office of Human and Animal Food -  
Division IV West
 


[1] Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)].
[2] Section 512(a)(2)(A)(i) of the Act) [21 U.S.C. § 360b(a)(2)(A)(i)].
[3] Section 512 of the Act [21 U.S.C. § 360b]
[4] Section 501(a)(6) of the Act [21 U.S.C. § 351(a)(6)].
[5] Section 512(a)(2)(A)(i) of the Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 360b(a)(2)(A)(i)] and section 501(a)(6) of the Act [21 U.S.C. § 351(a)(6)].

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