FDA 483 - Scientech Laboratories Inc - April 25, 2017

Scientech Laboratories Inc. in South Plainfield, New Jersey, received a Form 483 following an inspection that identified significant deficiencies in their control laboratory operations. The observations primarily concern inadequate employee training, improper sample handling, deficient method verification and validation, and failures in quality control unit procedures and record-keeping for analytical method modifications. These issues indicate a lack of robust quality systems for drug product testing.