FDA 483 - ADMA Biologics, Inc - April 12, 2018

The FDA Form 483 details multiple observations at a pharmaceutical manufacturing facility, indicating significant deficiencies in data integrity, quality control, and facility management.

**Data Integrity and Control:** * Failure to prevent unauthorized data access and changes, and to control data omissions. * Electronic data acquisition systems (e.g., (b)(4) System, (b)(4) Analyzer, (b)(4)) lack username/passwords, audit trails, or have "delete" functionalities. * No audit trail for creation/deletion of data files in the (b)(4) system for identity testing. * Data can be deleted from hard drives of analytical equipment computers (e.g., (b)(4)), with no electronic data backup procedures or performance. * (b)(4) workbooks (F-SAF-3049-a, F-SAF-3049-c) are not protected from alteration. * No procedures for audit trail review. * Personnel with administrator rights in (b)(4) and (b)(4) software are also responsible for data review/approval. * No periodic review of user roles/permissions in (b)(4).

**Document Control and GMP Records:** * Issuance and use of documents are uncontrolled. * No controls to ensure submitted paper documents are original; personnel can print GMP records without tracking, leading to excess printing