FDA 483 - Scientech Laboratories Inc - January 19, 2018

Scientech Laboratories Inc. in S Plainfield, NJ, was cited with four observations during an FDA inspection from January 2-19, 2018, primarily concerning inadequate laboratory controls and data integrity issues. The firm failed to ensure proper drug product release testing, maintain complete laboratory records, implement change control for software upgrades, and validate equipment like refrigerators for intended use. These issues indicate significant deficiencies in their quality control and assurance systems.