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Oyster and Manila clams advisory The implicated products in the Dec. 16 advisory include oysters and Manila clams harvested from Nov. 15, 2024, and Dec. 11, 2024, by Rudy’s Shellfish in ...
The FDA wants consumers and restaurants to avoid serving or eating — preferably, just throw out — a brand of frozen raw oysters distributed in 13 states and suspected of causing sapovirus ...
District offices do not recommend a Warning Letter as a follow-up to a preapproval inspection (PAI) for pending drug or device applications (ANDAs, NDAs, BLAs) if the firm markets no other FDA-regulated products. If the firm markets other FDA-regulated products and the issue(s) affect marketed products—or the inspection extended to marketed ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The FDA said in a warning last week that the shellfish were distributed to restaurants and food retailers, or purchased by consumers, in Arizona, California, Colorado, Hawaii, Nevada, New York ...
Ward Oyster Company is a cage oyster farm headquartered in Gloucester County, Virginia, and one of the largest cage oyster farms on the U.S. East Coast. [ 1 ] [ 2 ] Established in 1986, the company sells 4 million oysters and tens of millions of larvae each year.
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