FDA WARNING_LETTER - mary borba parente - October 05, 2012

On August 13, September 27, and October 5, 2012, the FDA investigated L&M Dairy, located at 8559 Edison Avenue, Ontario, California. The investigation found that L&M Dairy offered for sale animals for slaughter as food that were adulterated, violating section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

Specifically, two heifer calves from L&M Dairy, identified with back tags (b)(4) and (b)(4), were found to have neomycin residues in their kidney tissue at 11.36 ppm and 10.69 ppm, respectively. This exceeds the FDA's established tolerance of 7.2 ppm for neomycin in cattle kidney tissue, as codified in 21 C.F.R. 556.430.

L&M Dairy is responsible for ensuring its operations and distributed food comply with the law. The FDA requires prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure and/or injunction. A written response detailing corrective actions must be submitted to the FDA Los Angeles District within fifteen working days of receiving the letter. If corrections cannot be completed within this timeframe, the response must state the reason for