FDA WARNING_LETTER - Hoke Farms

On July 22, 2014, the FDA issued a Warning Letter to Hoke Farms following an investigation on May 7, 2014, of their dairy farm operation in Mount Pleasant, Pennsylvania. The investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act concerning the use of the new animal drug Combi-Pen-48. Specifically, Hoke Farms adulterated Combi-Pen-48 by not using it as directed by its approved labeling or veterinarian prescription label, constituting extralabel use. A critical deficiency was that this extralabel use was not under the supervision of a licensed veterinarian, directly violating 21 C.F.R. 530.11(a). This improper use rendered the drug unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. The letter emphasizes the firm's responsibility for ensuring compliance and requires prompt corrective action to prevent recurrence. Hoke Farms must respond in writing within fifteen working days, detailing corrective steps and providing documentation, or explaining any delays. Failure to comply may lead to further regulatory actions such as seizure or injunction.