During an inspection on July 31, 2024, the Food and Drug Administration (FDA) identified 13 violations concerning foodborne biological hazards at PureWater Dynamics, Inc., located in Denver, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training.’
- ‘You did not exclude pests from your food plant to protect against contamination of food.’
- ‘You did not have a written food safety plan.’
- ‘You did not fill, cap, close, seal and package containers in a sanitary manner so as to preclude contamination of the bottled drinking water.’
- ‘You did not take product water samples after processing and prior to bottling.’
- ‘You did not maintain records at the plant pertaining to physical inspection of equipment used for treatment of product water, including the type and date of physical inspections of equipment, conditions found and performance and effectiveness of equipment.’
- ‘You did not keep records of inspections and conditions found, physical maintenance and performance for mechanical washers.’
- ‘You did not sample and test cleaning and sanitizing solutions to assure adequate performance.’
- ‘You did not identify each unit package from a batch and segment of a continuous production run of bottled drinking water with a production code which identifies the particular batch, the segment of production run and the day produced.’
- ‘You did not record and maintain information as to the kind of product, volume produced, date produced, lot code used and distribution of finished product to wholesale and retail outlets.’
- ‘You did not take a bacteriological swab or rinse count at least every three months from at least four containers and closures selected just prior to filling and sealing.’
- ‘You did not take and analyze samples of bottled drinking water for bacteriological testing at least once a week for each type of bottled drinking water produced during a day’s production run.’
- ‘Samples collected for bacteriological, chemical, physical and radiological analysis were not primary containers or unit packages from a batch or segment of a continuous production run for each type of bottled drinking water.’
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
