FDA WARNING_LETTER - Girard Spring Water Co., Inc. - September 09, 2009

An FDA inspection of Girard Spring Water Co., Inc.'s bottled water manufacturing facility, conducted on August 25, September 3, and 9, 2009, revealed significant violations of the Processing and Bottling of Bottled Drinking Water regulations (21 CFR 129). These deficiencies render the firm's product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations include failures in critical quality control areas: inadequate sampling and analysis of source water for chemical, radiological, and microbiological contaminants, and insufficient testing of bottled water for bacteriological, chemical, physical, and radiological parameters. The firm also failed to properly inspect containers and closures, and did not adequately inspect its mechanical washer. Facility design issues were noted, such as the bottling room not being properly separated from other operations, oversized conveyor openings, and porous cement walls, all contributing to contamination risks. Further deficiencies included inadequate record maintenance, poor ventilation leading to condensation, unsanitary product water-contact surfaces, and unsanitary handling of caps, seals, and the overall filling and packaging process. The firm's initial response to the FDA 483 was deemed inadequate due to a lack of corrective action documentation. Girard Spring Water Co., Inc. is required to take prompt action to correct all violations and submit a written response within fifteen working days, detailing specific corrective steps, preventative measures, and supporting documentation. Failure to comply may lead to further regulatory actions, including product seizure or injunction.