FDA 483 - Waterlab Corporation - July 30, 2021

Waterlab Corporation, a contract testing laboratory in Salem, OR, was cited for significant deficiencies in its laboratory operations. Observations included inadequate verification of testing methods for pharmaceutical-grade water, insufficient quality assurance review of laboratory records, and a lack of scientifically sound test procedures. Additionally, the firm failed to calibrate instruments at suitable intervals and allowed an untrained analyst to perform critical testing, compromising the integrity of over 200 reported test results.