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  1. Warning Letters

WARNING LETTER

Sunshine Mills Inc MARCS-CMS 576411 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Animal & Veterinary
Food & Beverages

Recipient:
Recipient Name
Mr. Alan Bostick
Recipient Title
CEO
Sunshine Mills Inc

P.O. Box 676
Red Bay, AL 35582
United States

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

6751 Steger Drive
Cincinnati, OH 45237-3097
United States


June 25, 2019

WARNING LETTER

Via United Parcel Service
Next Day – Signature Required

Mr. Alan Bostick, CEO
Sunshine Mills, Inc.
P.O. Box 676
Red Bay, AL 35582

Dear Mr. Bostick:

The U.S. Food and Drug Administration (FDA) inspected your pet food manufacturing facility located at 2103 South Gloster Street, Tupelo, MS for nine days between November 14 and December 13, 2018. This inspection was conducted in response to consumer complaints that revealed elevated levels of vitamin D in your dog food and was a follow-up to your firm’s voluntary recall of multiple dog foods that contained potentially toxic amounts of Vitamin D. Our 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 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 dated January 2, 2019. We have reviewed your response and we discuss your significant violations and your corrective actions below.

The dog food products involved in the recall event included dry dog food that was manufactured between October 23, 2017 and November 2, 2018:

(b)(4)
(b)(4)
(b)(4)
(b)(4)
(b)(4)
(b)(4)
• (b)(4)
(b)(4)
(b)(4)

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.3

Adulterated Animal Food

During our inspection of your facility, FDA Investigators noted violations of the Hazard Analysis and Risk-Based Preventive Controls requirements for animal food found in Title 21 of the Code of Federal Regulations, part 507, subpart C (21 CFR part 507, subpart C). These violations render your animal food products adulterated according to the FD&C Act.4 Violations observed during the inspection include, but are not limited to, the following:

1. Your firm failed to identify and implement preventive controls to ensure that any hazards requiring a preventive control will be significantly minimized or prevented, as required in by 21 CFR 507.34(a)(1).

Specifically, you identified vitamin and mineral toxicity and deficiency as a hazard requiring a preventive control in your food safety plan. However, as evidenced by the toxic levels of vitamin D found in some of your dog foods, you failed to implement adequate preventive controls to ensure your inclusion of vitamin D did not result in a nutrient toxicity or deficiency.

Your hazard analysis determined that a preventive control was not necessary at ingredient receiving for “wrong levels” of vitamins in ingredients due to your “internal programs.” Your hazard analysis further determined that the process control of “batching/mixing” with a parameter of +/- 10% of the formula would serve as a preventive control for the hazard of “ingredient levels.”

Your “internal programs” consist of SOP number (b)(4) and SOP number (b)(4).” With regard to micro ingredients, SOP (b)(4) states that “all bagged raw materials will provide a Certificate of Analysis (COA), which will be maintained in the ingredient purchasing office.” (b)(4) says that “it is the policy of Sunshine Mills that all incoming shipments of raw materials used in our products, including bulk grains, bulk protein and other meals, bulk fats and tallows, salt, packaged vitamin and mineral supplements, color additives, and other ingredients will be examined at the time of receipt to assure that they are of good quality and meet product specifications. This examination will consist of a visual inspection for identity and gross visible defects, a test for moisture content as may be indicated, and sampling for assay of protein, fiber, vitamin and mineral levels or other purchase specifications, and also to check for contaminants.” It is also your policy that “vendors, from time to time, provide a COA for such things as vitamin and mineral content when this is part of the puce-chase [sic] specifications.”

However, these SOPs did not ensure that vitamin D levels in incoming ingredients met established ingredient specifications. For example, the vitamin D levels were not analyzed at a laboratory facility on a routine basis to ensure that the vitamin D met your firm’s pre-set formulation. You did not question any difference in appearance of the packaging or the ingredient. In addition, your firm did not obtain Certificates of Analysis (COA) upon receipt of each shipment of vitamin D. Furthermore, there is no indication of who is responsible for performing these actions listed in the SOPs or verifying that they have been performed or what steps are to be taken if an incoming ingredient does not meet specifications.

Your “batching/mixing” preventive control includes no measures that would prevent the use of an ingredient that is the wrong concentration.

Consequently, you used five shipments of an ingredient that you were unaware contained a higher concentration of vitamin D (500,00 IU/g) instead of the vitamin D with a lower concentration (7,500 IU/g) consistent with your firm’s formulation. This resulted in reports to FDA from pet owners and veterinarians that several dogs developed vitamin D toxicity after consuming your products.

2. Your firm failed to conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed or held at your facility to determine whether there are any hazards requiring a preventive control, in accordance with 21 CFR 507.33(a)(1).

Specifically, your firm manufactures cat food that includes thermal processing (extrusion) as a manufacturing step. Your hazard analysis did not identify inadequate thiamine in extruded dry cat food as a known or reasonably foreseeable hazard. Thiamine deficiency is a well-documented hazard for facilities that manufacture cat food that undergoes thermal processing.5

Thiamine (Vitamin B1) is an important vitamin that helps cats utilize carbohydrates as energy. However, thiamine is not heat stable, so during the processing of commercially produced pet food 50 to 90% of total thiamine added to the formulation could be lost due to high temperature heat treatment used during thermal processing (e.g., extrusion).6 Cats that develop thiamine deficiency can show symptoms such as bending of the neck in a downward position with inability to raise the head (cervical ventroflexion), muscle weakness, anorexia, wobbly gait, falling, seizures, and circling. If left untreated, thiamine deficiency can result in death. Cats are more susceptible to thiamine deficiency than dogs because cats have approximately a 4 times higher requirement for the vitamin than their canine counterparts.7 The Association of American Feed Control Officials (AAFCO) recommends a minimum for cats of 5.6 mg thiamine/kg of food on a dry matter basis.8

Corrective Actions

FDA acknowledges the receipt of your firm’s response to the Form FDA 483 dated January 2, 2019 that included your proposed voluntary corrective actions. You stated that these corrective actions include:

• Ingredient Tracking: All incoming shipments of ingredients will be tracked using the (b)(4) and will be rejected if not accompanied by a COA or letter of guarantee. All COAs received will be documented.

• Ingredient Specifications: All incoming lots of vitamins will be verified through random laboratory testing at least quarterly to ensure the specifications match those in the COA. Discrepancies will be reported to the vendor and the ingredient returned to them. The vendor will be required to take certain corrective actions and future shipments of vitamins will be tested.

• Finished Goods: Finished goods will be randomly tested for vitamin levels.

• Hazard Analysis: The hazard analysis was updated to include thiamine in extruded dry cat food as a known or reasonably foreseeable hazard likely to occur.

We are unable to evaluate your proposed corrective actions because you did not provide supporting documentation, such as an updated hazard analysis, revised procedures, test results, or other documentation, to show that you have implemented these proposed corrective actions.

Your response also did not discuss the reanalysis of your firm’s food safety plan as a result of your unanticipated food safety issue, as required by 21 CFR 507.50(b)(3). You also did not provide a timeframe in which you expect these corrective actions to be implemented.

FDA will verify your corrective actions during the next inspection of your firm.

Reportable Food Registry

You failed to report a reportable food to the Reportable Food Registry within 24 hours of determining 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 the FD&C Act.9 Specifically, your firm determined on November 2, 2018 that a reportable food event had occurred but you did not submit a reportable food report to FDA until November 11, 2018.

In your January 2, 2019 response, you stated that it was your understanding that the brand owners would initiate the reportable food registry submission. The Reportable Food Registry was established to provide a reliable mechanism to track patterns of adulteration in food (including animal food) to support efforts by FDA to target limited inspection resources to protect the public health. It requires a “responsible party” to file reportable food reports. The responsible party is the person who submits the registration under section 415 of the FD&C Act for a food facility that is required to register, at which the reportable food was manufactured, processed, packed, or held.10 Failure to submit a required reportable food report is a prohibited act under the FD&C Act.11 Your January 2, 2019 response stated that in subsequent situations your firm will adhere to the law when submitting a reportable food report. FDA will verify this during future inspections.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement 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 injunction.

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 firm’s response should be sent to Allison C. Hunter Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio, 45237. If you have questions regarding any issues in this letter, please contact Allison C. Hunter at 513-679-2700, extension 2134 or Allison.hunter@fda.hhs.gov.

Sincerely,
/S/

Steven B. Barber
Cincinnati District Director
Office of Human and Animal Food Operations
Division East 5
 

________________________

1 Section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)].

2 Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

3 Food and Drug Administration. 2019. “Vitamin D Toxicity in Dogs.” Accessed May 1, 2019. https://www.fda.gov/animal-veterinary/animal-health-literacy/vitamin-d-toxicity-dogs?fbclid=IwAR3C1wwV52pDKqs-VLDUg9ED9Gplv23ZL4YjzFPxYQWJCiWdYLqN0nXZ_T0

4 Section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1).

5 See FDA Draft Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals and associated references documenting thiamine deficiency as a known or reasonably foreseeable hazard in thermally processed cat food.

6 Crane SW, Moser EA, Cowell CS, et al. Commercial pet foods. In: Hand MS, Thatcher CD, Remillard RL, et al, eds. Small animal clinical nutrition. 5th ed. Topeka, Kan: Mark Morris Institute,2010;157–190.

7 Kritikos, G., et al. 2017. The Role of Thiamine and Effects of Deficiency in Dogs and Cats. Veterinary Sciences, 4(4):1-16: DOI:10.3390/vetsci4040059

8 Association of American Feed Control Officials’ Official Publication. 2018. Association of American Feed Control Officials. Champaign, IL.

9 Section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)].

10 Section 417(a)(1) of the FD&C Act [21 U.S.C. § 350f(a)(1)].

11 Section 301(mm) of the FD&C Act [21 U.S.C. § 301(mm)].