WARNING LETTER
Hi-Pro Feeds, LLC
MARCS-CMS 667790 —
February 01, 2024
Delivery Method:
UPS Overnight
Product:
Animal & Veterinary
Food & Beverages
Recipient:
Recipient Name
Mr. Clifton Morgan
Recipient Title
General Manager / President
Hi-Pro Feeds, LLC
1201 E. 11th Street
Friona
,
TX
79035-1410
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
February 01, 2024
WARNING LETTER
CMS# 667790
Dear Mr. Morgan:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your FDA licensed medicated feed manufacturing facility, located at 1201 E 11th St. Friona, TX 79035-1410 from July 31 through August 4, 2023. This inspection was initiated in response to a Reportable Food Registry (RFR) report your employee filed after receiving a consumer complaint involving multiple illnesses and deaths in your customer’s
(b)(4)
goat herd after consuming a medicated goat feed, Windy Acres Show Ration (lot number 0015932234), that was manufactured by your facility on April 19, 2023. Your third-party lab analyzed samples of goat feed from the customer as well as your retained samples and reported the presence of
(b)(4)
from urea, an animal feed ingredient for which the goat food was not formulated to include. Elevated urea levels can cause serious health consequences and death in ruminant animals such as cattle, sheep, goats, and deer. The sample results, the farm’s veterinarian’s statement, and necropsy reports from a goat that consumed this feed indicate the goats died from
(b)(4)
toxicity. Your facility conducted a recall of this goat feed on July 7, 2023.
During the inspection, FDA Investigator found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements in Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507) which causes your products to be adulterated.
1
The doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is prohibited.
2
Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls requirements of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act.
3
Additionally, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that an animal food is a reportable food (i.e., an animal food for which there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals).
4
Failure to submit a required reportable food report is a prohibited act.
5
You may find the FD&C Act and FDA’s regulations through links on the FDA’s website at https://www.fda.gov/.
At the conclusion of our inspection, you were issued a Form FDA 483, Inspectional Observations (FDA-483). We received your written email responses to these observations dated August 24 and September 5, 2023 and address your corrective actions below in relation to each of the noted violations.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigator obtained evidence of significant violations of these requirements, which included but were not limited to the following:
You did not conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food you manufacture, process, pack, or hold at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 507.33(a).
Specifically, your written hazard analysis failed to identify the known or reasonably foreseeable chemical hazard of nutrient toxicity associated with excess urea in the animal food you produce. Your facility uses urea as an ingredient in some of your products, which could be toxic at excess levels to goats and other species. On April 19, 2023, you manufactured
(b)(4)
of a custom medicated goat feed, Windy Acres Show Ration (lot number 0015932234), that was not formulated to contain urea but was subsequently found to contain elevated levels of
(b)(4)
from urea. On
(b)(4)
,
(b)(4)
50-pound bags were sold to a customer who fed the goat feed to their
(b)(4)
goats on May 7, 2023. The customer reported on May 7, 2023, that one goat was “bellowing in pain, foaming at mouth, labored breathing, restless, muscle and tail twitching, up and down, laid down, and died within two hrs of ingesting feed.” The customer subsequently reported additional goat deaths. You performed a root cause investigation and reasoned that the elevated levels of
(b)(4)
was due to loose bulk urea forming a plug in the distributor head and this plug, containing an unknown amount of urea, was dislodged into a bin of soybean meal that was subsequently used in the production of the Windy Acres Show Ration product.
Evaluation of your responses:
Your written responses to the FDA-483 included an updated Animal Food Safety Plan and hazard analysis dated August 21, 2023. In your updated hazard analysis, you address
(b)(4)
, but only at the “
(b)(4)
” step. Your hazard analysis does not fully address the known or reasonably foreseeable hazard of nutrient toxicity related to the use of urea in your animal food. For example, your hazard analysis does not address the other areas in which urea carryover could happen, such as at the distributor head or related conveyance steps. Further, your response does not indicate that you evaluated the likelihood of urea carryover at each step of your process where the hazards associated with urea could be introduced or enhanced, such as at the receiving step. We are unable to fully evaluate your corrective actions because you did not provide supporting documentation to demonstrate you have adequately evaluated nutrient toxicities and deficiencies at each production step where nutrient toxicities and deficiencies may be associated.
Reportable Food Registry (RFR)
You failed to report a reportable food to the RFR within twenty-four (24) hours of determining that an article of food is a reportable food, as required by section 417(d)(1) of the FD&C Act. Specifically, on May 7, 2023, your customer informed you that they observed multiple illnesses and deaths of
(b)(4)
goats that consumed Windy Acres Show Ration (lot number 0015932234), a medicated custom goat feed you manufactured. Your company responded by sending a sales representative to the customer’s farm to collect samples from opened bags of goat feed on May 8, 2023. Results from those samples were reported on May 17, 2023 and documented elevated levels of
(b)(4)
from urea, an ingredient the feed was not formulated to include. Subsequent sampling of retained samples and additional finished product were submitted for analysis and further demonstrated the presence of urea.; However, you did not file a RFR report until July 13, 2023.
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.
6
The responsible party is required to file a notification within 24 hours of determining that an article of food is a reportable food.
7
Failure to submit a required reportable food report is a prohibited act under the FD&C Act.
8
Conclusion
This letter is not intended to be an all-inclusive statement of 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 that you comply with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal action, including without limitation, seizure and injunction.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
Guidance for Industry #235: “Current Good Manufacturing Practice Requirements for Food for Animals” https://www.fda.gov/media/97464/download
Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program” https://www.fda.gov/media/113923/download
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Chad J. Whitwell, Compliance Officer, at chad.whitwell@fda.hhs.gov (preferred) or at U.S. Food and Drug Administration, 1201 Main St, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at 214-253-5328.
Sincerely,
/S/
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
cc: Mr. Mark W. Osborn, Plant Manager
Hi-Pro Feeds, LLC
1201 E 11th St
Friona, TX 79035-1410
cc: Mary Sasser, Program Director
Office of the Texas State Chemist
ATTN: Mary Sasser, Program Director
P.O. Box 3160
College Station, TX 77841-3160
__________________________
1
See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
2
See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
3
See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].
4
See Section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)].
5
See Section 301(mm) of the FD&C Act [21 U.S.C. § 331(mm)].
6
See Section 417(a)(1) of the FD&C Act [21 U.S.C. § 350f(a)(1)].
7
See Section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)].
8
See Section 301(mm) of the FD&C Act [21 U.S.C. § 331(mm)].
Content current as of:
04/30/2024
Regulated Product(s)
Animal & Veterinary
Food & Beverages