The U.S. Food and Drug Administration recently posted a warning letter that went out to Royal Lagoon Seafood Inc. of Theodore, AL. FDA’s New Orleans District Office wrote to the company on Sept. 22 to say that an inspection of its seafood processing facility on June 28 and 29 found “serious violations” of both the seafood Hazard Analysis and Critical Control Point (HACCP) and Current Good Manufacturing Practice regulations. The agency cited a failure to monitor and keep records for Scombroid (histamine) Formation fish. “The investigator found you are not monitoring the temperature of incoming fish, which is a critical control point for this hazard,” FDA wrote. “According to your HACCP plan, you monitor the temperature at this critical step and record it on the incoming Bill of Lading for those histamine forming products. Time and temperature abuse will highly escalate the potential of this pathogen to grow and cause consumer illness,” the agency added. The company’s July 9 response to the inspection’s findings was acknowledged but considered inadequate to address FDA’s concerns. “No data was provided to assure FDA you have taken corrective actions or that you understand the concept of HACCP implementation and the seriousness of processing histamine forming fish at your facility,” the agency wrote. Dietary supplement labeling warning On Sept. 23, FDA’s Los Angeles District Office sent a warning letter to SSO Inc., doing business as BYS Company, pointing out “serious violations” of federal Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These problems were noted during an inspection of the firm’s manufacturing facility in Lake Elsinore, CA, from Feb. 19 through March 18, according to the warning letter. They included failure to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement and for each batch size to ensure uniformity in the finished batch, as required by federal regulations. “Specifically, you have not prepared and followed a written MMR for your Cell Power in 1-ounce and 2-ounce bottles and Super Silica in 4-ounce bottles,” FDA wrote. Another issue mentioned in the agency’s letter concerned specifications for the water used as a component in the dietary supplement products. “Water is used as a component in your dietary supplements, but you do not conduct testing to show that your purification equipment is suitable for use and can produce potable water consistently,” FDA stated. The agency also noted several problems involving alleged mislabeling of the company’s Cell Power and Super Silica products, including incorrect serving sizes and how and where the dietary ingredients were listed. Regarding the company’s response dated April 5, FDA wrote that it “does not address any of the violations found at your facility; as a result, we are unable to evaluate the adequacy of any corrective actions you may have taken.” Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.
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