|Company:||Chickering, Arthur H III|
|Subject:||Active Pharmaceutical Ingredient/Adulterated|
|Issuer:||New England District Office|
|Issued:||June 17, 2005||Closed:||
Department of Health and Human Services
Public Health Service
New England District
June 17, 2005
VIA FEDERAL EXPRESS
RETURN RECEIPT REQUESTED
Arthur H . Chickering, III, Cattle Dealer
8 Sunter Road
Westmoreland, NH 03467
Dear Mr. Chickering:
An inspection of your cattle operation located in Westmoreland, New Hampshire was conducted by the Food and Drug Administration (FDA) on March 22 and 23, 2005. The inspection confirmed that you offered an animal for sale as human food in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The animal, a Holstein bob veal calf, was adulterated food within the meaning of Section 402(a)(4) the Act. The inspection also revealed that that you caused a medicated feed to be adulterated within the meaning of Section 501(a)(6) of the Act.
On or about January 25, 2005, you offered for sale a calf without identification for slaughter as human food. The calf was transported to [redacted] where it was given Sale Tag number [redacted] and sold and transported to the [redacted] for slaughter. The United States Department of Agriculture (USDA/Food Safety and Inspection Service (FSIS) analysis of kidney tissues collected from the animal revealed the presence of Neomycin at a level of 4.22 parts per million (ppm). The animal was identified by tag [redacted]. The animal was slaughtered on January 26, 2005.
You adulterated the medicated feed, [redacted] milk replacer. The manufacturer's label specifies that the product should not be used in calves to be processed as veal. Your actions caused the medicated feed to be adulterated within the meaning of Section 501(a)(6) of the Act, in that it is a new animal drug within the meaning Section 201(v) of the Act, and is unsafe within the meaning of Section 512(a)(I)(B) of the Act because' it was not used in conformance with its approved labeling. The Act does not permit extralabel use of a medicated feed:
The investigation also found that you hold animals under conditions that could allow medicated animals, bearing potentially harmful drug residues, to enter the food supply.
Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Act.
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to correct the violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.
The violations listed above are not intended to be an all-inclusive list. It is your responsibility to ensure that your operations are in compliance with the law.
You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce. The fact that you caused the adulteration of an animal that was subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
You should notify this office in writing within fifteen (15) working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken or that will be taken to correct the violations and prevent their recurrence. If corrections cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that
corrections have been made.
Your reply should be addressed to the Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180, Attention: Bruce R. Ota, Compliance Officer.
New England District