FDA WARNING_LETTER - Robert A. Miller - January 23, 2013

On January 22-23, 2013, the FDA inspected Robert A. Miller's dairy operation in East Waterford, Pennsylvania, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation was the adulteration of the new animal drug Norocillin (Sterile Penicillin G Procaine Injectable Suspension) NADA 065-010.

Specifically, the investigation revealed extralabel use of penicillin G procaine on a dairy cow (ear tag (b)(4)) without adhering to the approved labeling's dosage, dosage per injection site, and conditions for use. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and 21 C.F.R. Part 530. Consequently, the drug was rendered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

The FDA requires prompt corrective action to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps must be submitted to Richard C. Cherry, Compliance Officer, within fifteen working days of receiving the letter. If corrections cannot be completed within this timeframe, a reason for delay and a new timeline must be provided, along with supporting documentation.