Len-acres – FDA Warning Letter, Mar 26, 2010

On March 23 and 26, 2010, the FDA inspected a dairy operation at 9179 Bloom Road, Lynden, Washington. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

A dairy cow sold for slaughter on December 4, 2009, was found to have Sulfadimethoxine in its liver at 1.160 ppm, exceeding the FDA tolerance of 0.1 ppm (21 CFR 556.640). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The operation also lacked an adequate system to prevent medicated animals with harmful drug residues from entering the food supply, leading to adulteration under section 402(a)(4) of the Act. Deficiencies included incomplete drug treatment records, specifically lacking: reason for drug use, route of administration, person administering the drug, and drug withdrawal timeframe. Additionally, there was no written inventory system for animal drugs used.

Furthermore, on December 4, 2009, an employee provided a false Drug Residue Affidavit for the aforementioned cow, certifying it as drug residue-free, which is prohibited by section 301(h) of the Act.

The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions