FDA EIR - Famous Ramona Water Inc - August 12, 2015

An FDA inspection of Famous Ramona Water Inc. in Ramona, CA, took place from August 11-12, 2015. Conducted under domestic food safety and bottled water regulations, the inspection revealed a primary observation: the company's finished bottled water did not comply with quality standards for phenols. Both purified and spring water samples exhibited phenol levels exceeding the regulatory limit of 1 ppb (µg/L), with findings up to 1.7 µg/L in purified water and 1.1 µg/L in spring water, and 1.4 µg/L in source water, contrary to standards outlined in 21 CFR 165. Furthermore, it was noted that the company's equipment logs lacked required documentation for physical inspections, including observed conditions and equipment performance effectiveness. Vice President Mark K. Filer was issued an FDA Form 483 for the bottled water quality deficiency. Management committed to investigating the elevated phenol levels with their testing laboratory, specifically reviewing sampling methods. Mr. Filer also pledged to review regulations to ensure equipment logs are properly maintained with comprehensive inspection details. Previous deficiencies identified in a 2009 inspection were reported as having been voluntarily corrected.