1. Failure to validate and monitor the water purification system to ensure that water is of appropriate quality and suitable for its intended use.Well, that sure doesn't sound very appetizing. Here's hoping they fix that hole.
During the inspection, our investigators found that your water purification system was not adequately monitored and controlled. Because you use water as a drug component and for cleaning your facility and equipment, these failures pose significant risk to the safety of your drugs.
Source waterYou failed to test the source water for your [redacted] water system. The source water emanates from a nearby river and passes through farmland, where it is subject to agricultural runoff and animal waste, before reaching your facility. Your firm stores the source water in an [redacted] tank that has a large [redacted]-facing hole that is open to the environment. Your storage method does not protect your water from dirt and other contaminants, or from the ingress and proliferation of pests and objectionable organisms.
Wednesday, March 15, 2017
Warning Letter of the Week: questionable water source edition
An unhappy epistle from the Food and Drug Administration to the Chief Executive Officer of
Badrivishal Chemicals & Pharmaceuticals: