FDA WARNING_LETTER - Chesapeake Valley Water Co - July 02, 2013

On June 18-July 2, 2013, the FDA inspected Chesapeake Valley Water Co.'s manufacturing facility, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the manufactured foods adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions potentially leading to contamination or injury to health.

Specific violations include: 1. Failure to adequately clean food-contact surfaces (21 CFR 110.35(d)): A grey, grease-like substance was observed on 20 oz. bottle filling equipment gaskets, which contact bottle lips during filling. 2. Plumbing constituting a contamination source (21 CFR 110.37(b)(3)): Waste lines from the water softener and washer/fill station were directly plumbed into floor drains without an air gap, posing a contamination risk to product and process water. 3. Failure to protect against contamination of food packaging systems (21 CFR 110.10(b)): An employee operated a forklift, then touched a rinsed, inverted 20 oz. bottle and reached into a hopper of sealing caps for 5-gallon bottles without washing hands.

The FDA requires prompt corrective action within fifteen working days of receiving the letter, detailing