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MARCS-CMS 659181 — SEPTEMBER 11, 2023 Recipient: Mr. Craig A. Friedman: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery products manufacturing facility located at 283 Thompson Avenue, Louisville, KY 40206 from February 27 through March 13, 2023. [link] Desserts by Helen, Inc.
On July 26, 2023, you were observed taking only a single temperature during the cooking step for a batch of clam chowder which was observed to be (b)(4); however, you did not continue to measure the temperature for a period of (b)(4) to ensure that the clam chowder stayed at (b)(4) to ensure pathogen reduction as required by your HACCP plan.
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