FDA EIR - Paks Clothiers (dba) Aqua Pure Drinking Water - April 13, 2015

An FDA inspection of Paks Clothiers (dba) Aqua Pure Drinking Water, a bottled water manufacturer in El Monte, CA, was conducted from April 6 to April 13, 2015. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act and related regulations (e.g., 21 CFR 129), identified ten significant violations. Issues included finished bottled water failing quality standards due to unquantified coliform and lack of E. coli testing, inadequate analysis of product water treatment, and infrequent or deficient bacteriological testing of containers with excessive bacterial counts and coliform presence. Furthermore, sanitizing operations for water-contact surfaces were deemed inadequate, lacking proper testing and record-keeping for solution strength and contact time. Facility issues involved a bottling room not adequately separated by tight walls and self-closing doors, and a failure to provide sufficient pest control, evidenced by an observed fly and ineffective pest devices. Operational Manager Mr. Umesh C. Pithia promised immediate corrections for several items, including enhanced testing protocols and record-keeping. For other issues, such as sanitation procedures and facility enclosures, he committed to researching solutions with suppliers and conducting further internal review, pledging a written response within 15 business days. He also agreed to instruct employees against storing personal items on machinery.