FDA 483 - Pharmatech Inc. - August 03, 2018

Pharmanatech Inc., a dietary supplement contract manufacturer in Lindon, UT, was cited for significant deficiencies in its manufacturing records. The inspection revealed failures to prepare master manufacturing records for each batch size, incomplete instructions within those records, and inadequate batch production records lacking essential details like equipment identification and blend/mix times. These issues indicate a lack of proper control over the manufacturing process for dietary supplements.