The U.S. Food and Drug Administration (FDA) has issued a warning letter on February 28 to Sunshine Mills, Inc., of Red Bay, Alabama. The letter, dated March 7, was made public by the FDA on April 18.
According to the letter, the FDA inspected the manufacturer’s facility located in Tupelo, Mississippi for 15 days between July 19 and September 1, 2021. The inspection was conducted as a follow up to a regulatory meeting between the FDA and Sunshine Mills on March 26.
The letter noted that Sunshine Mills has conducted five recalls of products manufactured at its Tupelo plant between August 24, 2020 and July 29, 2021. In addition, the letter stated the FDA’s inspections revealed violations of its Current Good Manufacturing Practice requirements for animal food, with references to the following documented instances:
“On August 9, 2021, during the current FDA inspection, investigators collected environmental swabs. Salmonella spp. was found on a compressed air nozzle, including the hose and reel, located in your post lethal treatment (b)(4) room between (b)(4) and (b)(4). Your firm utilizes compressed air nozzles to blow off floors and equipment. FDA investigators observed at least two employees who were using compressed air to remove adhered food debris on equipment cause a nozzle to come in direct contact with food contact surfaces by scraping the surfaces with the nozzle.”
“During production on (b)(4), and August 18, 2021, FDA investigators observed rust and corrosion on your (b)(4) buckets on (b)(4) Line (b)(4) and (b)(4) Line (b)(4). These areas are post lethal treatment direct food contact surfaces.”
“On July 22, 2021, water was observed seeping from the floor of the (b)(4) room. The pool of standing water was also observed serving as a harborage area for approximately 40 apparent live fly insects. A water hose used for cleaning floors, walls, and post lethal treatment pet food equipment exteriors was also observed making direct contact with the floor approximately ½ -inch from the standing water.”
The conclusion of the warning letter included the following statement:
“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 frame 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. In addition, please be prepared to discuss your reasoning and any supporting information during our upcoming teleconference regulatory meeting.”
The FDA responded to Pet Age’s request for an update by stating the following: “The FDA is currently conducting [a] follow-up, but we aren’t able to share any further details publicly at this time.”
A message for comment was left with Tim Taylor, vice president of Quality & Food Safety at Sunshine Mills.