FDA 483 - AptaPharma Inc. - March 16, 2018

Apta Pharma, Inc. in Pennsauken, New Jersey, received a Form FDA 483 citing four observations related to deficiencies in their laboratory, quality, and material systems. The inspection revealed issues including incomplete laboratory records for reference standards, inadequate process validation, and a lack of a robust drug product recall system with unapproved labeling. Additionally, the firm was cited for insufficient controls over electronic data, which allowed for the alteration of analytical records.