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WARNING LETTER
•Glick, Jonathan J.•January 17, 2008

Glick, Jonathan J. – FDA Warning Letter, Jan 17, 2008

Record Details

On May 28, 2008, the FDA issued a Warning Letter to Jonathan J. Glick, owner of a dairy operation in Howard, Pennsylvania, following a January 17, 2008, investigation. The investigation confirmed the sale of an adulterated animal for slaughter.

Specifically, on or about September 6, 2007, a cow sold by Glick for slaughter contained sulfadimethoxine residues in its liver (3.05 ppm) and muscle (1.41 ppm), exceeding the established tolerance of 0.1 ppm. This violated sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), rendering the food adulterated.

The FDA also found that Glick's operation lacked an adequate system to ensure medicated animals were withheld from slaughter for appropriate periods, increasing the likelihood of drug residues entering the food supply. A specific deficiency noted was the failure to maintain treatment records.

Glick is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines must be submitted to the FDA within fifteen working days of receiving the letter. Failure to comply may result in regulatory actions, including seizure and/or injunction.

Company
Glick, Jonathan J.
Inspection date
January 17, 2008
Product type
Drugs
Office
Philadelphia District Office
People
  • Thomas D. Gardine (District District Director)
  • David R. Griswold
View Company Profile

ID · 28bc61e1-dc70-443c-ad44-0136b72266fe

Violation Codes3
21 U.S.C. 342(a)(2)(C)(ii)21 U.S.C. 342(a)(4)21 CFR 556.640

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