Sunshine Mills, Inc
Sunshine Mills, Inc., a pet food manufacturer in Tupelo, MS, received an FDA Warning Letter following a 15-day inspection revealing significant violations of Current Good Manufacturing Practice and Hazard Analysis/Risk-Based Preventive Controls regulations (21 CFR Part 507). The violations centered on failure to implement preventive controls for mycotoxin (aflatoxin) contamination and Salmonella recontamination, inadequate corrective action procedures, and insanitary facility conditions including roof leaks and standing water. The letter is not related to human health marketing claims and falls outside the scope of physician-led health clinic marketing enforcement; no health marketing claims were flagged.
Required actions (3)
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.
We will verify the implementation and sustainability of your corrective actions during an inspection of your firm at a later date.
Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.
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