HUMAN DRUGS: 6803W

Nu-Wave Health Products, Tampa, FL, June 24 (Florida). GMP deviations related to Arth-Rx with Neurocaine topical lotion included failure to validate manufacturing processes and non-USP test methodologies; a lack of written specifications, test procedures and a sampling plan; failure to establish the reliability of a contract testing lab=s finished product analysis; distribution before reviewing test results; stability testing deficiencies; unvalidated cleaning procedures; a lack of environmen-tal controls and master production records; incomplete batch records; and a lack of written procedures for the contractor=s stability studies, equipment maintenance and calibration, the retain/reserve sample area, the deionized water system and the documentation of in-process checks. Two lots were deemed adulterated for containing more than the declared amount of capsaicin. Misbranding resulted from failure to register the establishment. The audit occurred Jan. 21-29.