Sweet Springs Valley Water Co. Receives FDA Warning Letter
The U.S. Food and Drug Administration (FDA) has cited Sweet Springs Valley Water Co. for violating federal regulations regarding its bottled water products. The agency sent a warning letter stating that products were adulterated due to unsanitary conditions. Regulators said the bottled water may be contaminated with E. coli, presenting a health risk to consumers.
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The warning letter, dated Mar. 7, 2017, refers to an FDA inspection that took place last August. “Our inspection revealed significant violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129,” the FDA said. “These violations render the bottled water products processed at your facility adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. §342(a)(4), because they have been prepared, packed, or held under insanitary conditions where by they may have become contaminated with filth, or whereby they may have been rendered injurious to health.”
Sweet Springs Valley responded to the investigation findings in August 2016, and the FDA addressed these responses in the warning letter. According to the FDA, several tests during inspection showed that the water tested positive for E. coli bacteria. Under federal regulations, the company is required to remedy the contamination immediately. A total of five samples must be tested over 24 hours to show that the water tests negative for E. coli. According to the letter, Sweet Springs Valley failed to do this. “Your response stated that this occurred due to an oversight, however you did not provide any information regarding how you intend to achieve compliance with this part of the regulation,” the FDA noted.
Facility Cited for Unsanitary Conditions, Manufacturing Violations
The agency also cited other violations related to the E. coli contamination. According to the letter, the company failed to keep records of corrective measures and conduct follow-up testing to ensure that the finished product does not contain the bacteria. Furthermore, samples contained more bacteria than allowed under regulations. The company also failed to show that their bottled water met the maximum allowable level for phenols, the FDA said.
According to the FDA, Sweet Springs Valley conducted testing in March 2015 and found that one out of five samples tested positive for E. coli. Despite this finding, regulators said, the company apparently continued to use the source water. The company cited a charting error and claims that it switched to a different water source, but the letter says there is no evidence of this claim.
The letter also states that bottles failed to meet requirements regarding ozonated water. The FDA also noted other unsanitary conditions, and “observed the spray of product water on the ceiling, sides and other interior surfaces of the firm’s machinery and the water subsequently dripped inside the finished product,” the letter said.
“We also observed areas of rust and hard water deposits. Your response indicated that you have adjusted the filler on the machine. You did not provide any information on how you plan to prevent product contamination from rust and hard water deposits inside the filler.”
E. coli is a type of bacteria that resides in the intestines of humans and other animals. There are many different strains of E. coli; most are harmless, but some can cause serious illness such as E. coli O157:H7. Symptoms of E. coli infection usually occur three or four days after being exposed to food or water contaminated with the bacteria, and may include:
• Diarrhea (can be mild and watery to severe and bloody)
• Cramping, pain or tenderness in the abdominal area
E. coli is present in human and animal feces. Ground and surface water can become contaminated with E. coli. According to Mayo Clinic, public water systems kill E. coli using chlorine, ultraviolet light or ozone. Contamination is more likely to occur in private wells and rural water supplies. People can also be exposed to E. coli through contaminated pools or lakes.
Legal Help for Food Poisoning Victims
If you or someone you know became exposed to E. coli or another pathogen through contaminated food products, you may have valuable legal rights. The food safety attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).