The U.S. Food and Drug Administration (FDA) recently posted warning letters sent to a bottled water manufacturing facility in St. Louis, MO, and a seafood processing facility in Yantai, China. FDA’s Southwest Region office in Lenexa, KS, sent a Feb. 26, 2015, warning letter to Unlimited Water Processing Inc. informing the company that an inspection of its St. Louis facility in November 2014 revealed “serious deviations” of the Processing and Bottling of Bottled Drinking Water Regulations. While acknowledging the firm’s Dec. 3, 2014, response, FDA’s letter indicated that the agency “remained concerned about the significant violations, as well as the corrective actions you described … .” These included alleged failure to do follow-up testing on certain manufactured 5-gallon returnable bottle water production lots, which FDA stated had tested positive for total coliform, to determine if they were positive for E. coli. The agency also stated that weekly production samples were not analyzed for total coliform nor were records maintained regarding the physical inspection of treatment equipment, among other problems cited. FDA’s office in College Park, MD, sent a letter dated Feb. 13, 2015, to Yantai Shanhai Foodstuff Co. Ltd., which processes various types of seafood in Yantai, Shandong Province, China. The letter stated that FDA inspectors had visited the facility in September 2014 and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. Because of these alleged violations, FDA stated that the firm’s “frozen, vinegar-soaked mackerel pieces, frozen crab flesh, and frozen mackerel fillet/piece products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.” Specifically, FDA stated that the company must conduct a hazard analysis to determine whether there are food safety hazards “reasonably likely to occur” and have a HACCP plan listing the critical control points for processing of the frozen, vinegar-soaked mackerel pieces to control the identified hazard of scombrotoxin (histamine) formation. The same point was made for the raw material mackerel and the raw material crab meat. FDA also stated that a processing critical control point needed to be listed for the frozen crab flesh. “Our investigator observed that your crab product undergoes significant handling after thawing under unrefrigerated conditions. Significant handling under unrefrigerated conditions poses a risk for pathogen growth including Staphylococcus aureus growth and toxin formation,” the warning letter stated. FDA further told the company that since it received sulfite-treated crab (e.g., at levels greater than 10 ppm), it must make sure that sulfites are declared on the labels of each individual package, and the agency recommended that a visual check be made of each label batch to ensure that the sulfites are properly declared. The company’s Oct. 15, 2014, emailed response was noted in the warning letter, but FDA stated there was no revised HACCP plan provided for the frozen, vinegar-soaked mackerel pieces. “We have evaluated the documentation and found that you have continuing serious deviations from the seafood HACCP regulation, as further explained in this letter,” the agency stated. In each warning letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.