Inspections, Compliance, Enforcement, and Criminal Investigations
Southern States Frederick Cooperative, Inc. 29-May-07
Department of Health and Human Services
Public Health Service
Baltimore District Office
May 29, 2007
RETURN RECEIPT REQUESTED
Mr. Gary L. Grossnickle, President
Southern States Frederick Cooperative, Inc.
6606 West Broad Street
Richmond, Virginia 23230-1717
Dear Mr. Grossnickle:
An inspection of your medicated feed mill, located at 500 East South Street, Frederick, Maryland, conducted by an U.S. Food and Drug Administration (FDA) investigator on March 5-8, 2007, found significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection revealed the medicated feed distributed by your firm was adulterated within the meaning of section 402(a)(2)(C) of the Act [21 U.S.C. § 342(a)(2)(C)] and misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
The inspection revealed your firm manufactured and distributed animal feed mixed with [redacted], a liquid supplement that contains [redacted] (lasalocid sodium). Under the Act, any substance intentionally added to a food must be used in accordance with a food additive regulation, unless it is generally recognized as safe ("GRAS") or meets one of the enumerated exceptions. Under section 409 of the Act [21 U.S.C. § 348], food additives are deemed unsafe unless they are used in accordance with a food additive regulation approving the substance for that use. Neither [redacted] nor lasalocid sodium are approved food additives, and we are not aware of any basis to conclude that they are GRAS for use in animal feed. The animal feed is thus adulterated under section 402(a)(2)(C) of the Act [21 U.S.C. § 342(a)(2)(C)] because it contains an unsafe food additive. [We note that the lasalocid sodium added to the animal feed would not be considered a food additive if, based on its intended use, it meets the definition of a new animal drug within the meaning of section 201(v) of the Act [21 U.S.C. § 321(v)]. The animal feed you distributed would nonetheless be adulterated under section 402(a)(2)(C) of the Act [21 U.S.C. § 342(a)(2)(C)] because it would contain a new animal drug that is unsafe within the meaning of section 512 of the Act [21 U.S.C. § 360b]. A new animal drug, such as [redacted], is considered unsafe if its use or intended use is not in accordance with its approved application.]
In addition, animal feed you distributed was returned by some customers because it contained [redacted] (lasalocid sodium), and you subsequently distributed this feed to other customers without a label. This animal feed is misbranded under section 403 of the Act [21 U.S.C. § 343] because, for example, it does not have a label that bears a statement of identity of the feed and the name of the ingredients, as required by Title 21, Code of Federal Regulations, sections 501.3 and 501.4 (21 CFR 501.3 and 501.4). The animal feed does not meet any exemption from these requirements.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for ensuring that your overall operations and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.
You should notify this office in writing, within fifteen (15) working days of receipt of this letter of the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made
Your reply should be sent to the Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, Attention: Steven B. Barber, Compliance Officer. Mr. Barber can be reached at (410) 779-5134.
Mr. David J. Stas, Manager
Southern States Frederick Cooperative, Inc.
500 East South Street.
Frederick, Maryland 21705
Mr. Warren R. Bontoyan
Maryland Department of Agriculture
50 Harry S. Truman Parkway
Annapolis, Maryland 21401