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WARNING LETTER
•A&G; Dairy Farms•July 29, 2013

A&G; Dairy Farms – FDA Warning Letter, Jul 29, 2013

Record Details

On September 24, 2013, the FDA issued a Warning Letter to A & G Dairy Farms following an investigation conducted on July 23, 25, and 29, 2013, at their Crows Landing, California, dairy operation. The letter notified owners Alvin S. Melo and George Melo of violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning the adulteration and extralabel use of new animal drugs.

The FDA found that A & G Dairy Farms adulterated and improperly used (b)(4) (penicillin-dihydrostreptomycin (b)(4)), (b)(4) (ceftiofur (b)(4) Sterile (b)(4)), and (b)(4) (isoflupredone acetate) Sterile Aqueous Suspension, (b)(4).

Specific violations include: - Administering (b)(4) (penicillin-dihydrostreptomycin (b)(4)) mixed in cow's colostrum to bob veal calves, violating the labeled prohibition against using colostrum as food for 96 hours after calving and the servicing veterinarian's prescription. This extralabel use was in or on feed, violating 21 C.F.R. 530.11(b), rendering the drug unsafe and adulterated under sections 512(a) and 501(a)(5

Company
A&G; Dairy Farms
Inspection date
July 29, 2013
Product type
Drugs
Office
San Francisco District Office
Person
  • Kathleen M. Lewis
View Company Profile

ID · ec32edae-72f4-4470-95f4-199138ec07c2

Violation Codes10
21 CFR 530.3(a)21 U.S.C. 360b(a)(4)21 U.S.C. 360b(a)(5)21 CFR 530.11(b)21 U.S.C. 360b(a)21 U.S.C. 351(a)(5)21 CFR 530.11(a)21 CFR 530.41(a)(13)21 U.S.C. 351(a)(6)21 U.S.C. 360b

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