FDA WARNING_LETTER - Richards, Douglas L. - July 10, 2008

The FDA conducted an investigation of Douglas L. Richards' dairy operation in Rome, New York, on June 18, July 2, and July 10, 2008. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter was found to be adulterated, containing sulfamethazine residues (9.58 ppm in liver, 8.79 ppm in muscle) for which no FDA tolerance exists in lactating dairy cattle, violating 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, animals were held under inadequate conditions, such as incomplete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, constituting adulteration under 21 U.S.C. § 342(a)(4). The firm also adulterated the new animal drug Sulfa-Max III Calf Bolus by using it extralabel, specifically administering it to lactating dairy cows, which is a prohibited extralabel use per 21 C.F.R. 530.41(a)(9). This non-conformance with approved labeling and 21 C.F.R. Part 530 rendered the drug unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). Richards is required to take prompt corrective action, establish preventative procedures, and respond in writing within fifteen working days detailing these actions and timelines to avoid further regulatory action.