# FDA WARNING_LETTER - Hoke Farms - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/hoke-farms/0c1e17c2-fbd4-4f2c-883c-707a677d7187

> FDA WARNING_LETTER for Hoke Farms on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hoke Farms
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: 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.

## Related Officers

- [District Director](https://www.keypedia.com/people/kirk-d-sooter/0357e0b4-b30c-444a-9994-26bf961a08ba)

Company: https://www.keypedia.com/companies/hoke-farms/ba4e15ec-e8bb-4011-b55b-8c449fd12f6d

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8