FDA WARNING_LETTER - Loek Van Warmerdam Dairy - February 03, 2012

On January 31 and February 3, 2012, the FDA inspected Loek Van Warmerdam Dairy in Nicolaus, California, and found significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed that the dairy operation adulterated new animal drugs, specifically (b)(4) (sulfadimethoxine) and (b)(4) (ampicillin for injectable suspension). This adulteration stemmed from the extralabel use of these drugs, meaning they were not used as directed by their approved labeling, as defined by 21 C.F.R. 530.3(a). Specifically, the dairy administered (b)(4) (sulfadimethoxine) to a lactating first-calf heifer without following approved indications, which is explicitly prohibited for lactating dairy cattle under 21 C.F.R. 530.41(a)(9). Furthermore, (b)(4) (ampicillin for injectable suspension) was administered to another first-calf heifer without following approved labeling and, critically, without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). These actions rendered the drugs unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. The FDA requires prompt corrective action, including establishing procedures to prevent recurrence. The firm must respond in writing within fifteen working days, detailing corrective steps and timelines, with potential regulatory actions like seizure or injunction for non-compliance.