As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Manzanola Feeds, LLC
An animal food firm in Colorado is on notice from the FDA after an inspection of its animal food manufacturing facility. The inspection was conducted as part of an FDA investigation into a multi-state foodborne outbreak of Clostridium botulinum toxicosis implicated in approximately 52 equine deaths and additional illnesses.
On Dec. 17, 2022, the U.S. Food and Drug Administration cautioned horse owners not to feed Top of the Rockies alfalfa cubes with the certain date codes. These alfalfa cubes were recalled by Manzanola Feeds, which distributes products directly to farms, feed stores and co-ops in eight states.
The FDA received reports of at least 98 horses, with symptoms consistent with botulism, in Colorado, Louisiana, New Mexico, and Texas. At least 52 of these horses died or were euthanized because of declining health.
On Jan. 19, 2023, FDA finalized laboratory testing of samples of Top of the Rockies alfalfa cubes that confirmed the presence of Clostridium botulinum type C, a bacteria that can lead to botulism.
Botulism develops if a person or animal ingests the toxin — and rarely, if the toxin is inhaled or injected — or if the organism grows in the intestines or wounds and toxin is released. Foodborne botulism is spread by consuming food contaminated with the botulism toxin or spores.
Botulism is a paralyzing disease affecting the body’s nervous system that is caused by the ingestion of one of the potent neurotoxins produced by Clostridium botulinum bacterium. This neurotoxin is among the most toxic substances known.
In a May 11, 2023, warning letter, the FDA described a Dec. 14, 2022, through Feb. 1, 2023, inspection of Manzanola Feeds, LLC’s animal food manufacturing facility in Manzanola, CO.
The FDA’s inspection found serious violations of of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation and resulted in the issuance of an FDA Form 483.
Current Good Manufacturing Practice (CGMP) Requirements
The firm’s animal food facility is subject to the CGMP requirements.
1. The firm did not examine raw materials and other ingredients to ensure that they are suitable for manufacturing and processing into animal food and are handled under conditions that will protect against contamination and minimize deterioration as required.
FDA investigators observed the firm using alfalfa hay bales that are approximately 3 feet by 4 feet by 8 feet and, therefore, have significant internal volume, in the manufacture of their alfalfa cubes. Their practice of inspecting only the exterior of these large hay bales is not adequate to identify the presence of an animal carcass baled into the hay that would render it unsuitable for manufacturing into animal food. As a result, foodborne disease outbreaks like the one described above could occur.
Evaluation of their response:
The firm’s response states they dispute the FDA’s observation because they inspect the exterior of each hay bale for foreign objects and it is impractical to inspect the interior of hay bales, and/or inspection “should be done at the local/farmer level, not by Manzanola.” The firm also stated they were reviewing their processes to consider whether additional measures can be implemented, including researching the possibility of using an X-ray or similar machine and implementing “more intense visual inspections.”
As a manufacturer of animal food, they are responsible for ensuring the food they introduce into interstate commerce is not adulterated, including complying with the CGMP requirements. Their practice of inspecting only the exterior of large hay bales is not sufficient, and their response is inadequate because they have not yet implemented corrections to ensure the interior of the large bales they use to make their product are not contaminated with animal carcasses, according to the warning letter.
Hazard Analysis and Risk-Based Preventive Controls Requirements
The firm’s animal food facility is subject to the hazard analysis and risk-based preventive controls requirements. FDA inspection identified a significant violation of these requirements.
The firm did not prepare, or have prepared, and did not implement a written food safety plan, as required. The preparation of the food safety plan must be overseen by their preventive controls qualified individual (PCQI) and must include the following:
a. The written hazard analysis
b. The written preventive controls
c. The written supply-chain program
d. The written recall plan
e. The written procedures for monitoring the implementation of the preventive controls
f. The written corrective action procedures
g. The written verification procedures
During the inspection, the firm told an FDA investigator that they did not have a food safety plan. At the close of the inspection, they indicated they had developed a food safety plan, but it did not identify Clostridium botulinum as a known or reasonably foreseeable hazard. There is a known association between illness caused by Type C botulism and the ingestion of animal food containing animal carcasses contaminated with the pre-formed Clostridium botulinum toxin Type C. Furthermore, as described above, one lot of their animal food has previously been shown to contain botulinum toxin. The firm stated they could revise the food safety plan.
The full warning letter can be viewed here.
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