FDA 483 - Wassco Bottling Company - September 14, 2017

An FDA inspection of Wassco Bottling Company, a bottled water manufacturer located in Tulsa, Oklahoma, was conducted on September 14, 2017. The inspection, documented on an FDA Form 483, identified two significant observations related to the company's quality control and microbiological testing practices. Firstly, the company did not conduct bacteriological swab or rinse counts from containers and closures, selected just prior to filling and sealing, at least every three months. Company personnel explicitly stated that this testing on bottles and caps used in manufacturing was not performed. Secondly, the inspection revealed that Wassco Bottling Company failed to take and analyze samples of its bottled drinking water for bacteriological testing at least once a week for each type of water produced during a day's run. The firm indicated a different, unspecified frequency for product testing, which did not meet the required weekly standard. These observations highlight deficiencies in the company's microbiological monitoring program for bottled water products. While an FDA Form 483 represents preliminary inspectional findings, Wassco Bottling Company is expected to implement prompt corrective actions to address these issues and ensure compliance with regulatory standards for bottled water manufacturing.