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

Source: https://www.keypedia.com/records/483/adma-biologics-inc/7e6697ae-e4d9-46bc-85b0-816179d3ad68

> FDA 483 for ADMA Biologics, Inc on April 12, 2018. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ADMA Biologics, Inc
- Inspection Date: 2018-04-12
- Office Name: Office of Biological Product Operations
- Summary: 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

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## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [COO / Vice President](https://www.keypedia.com/people/michael-l-forster/93e914d1-417a-4520-85b7-7c43aba43c92)

Company: https://www.keypedia.com/companies/adma-biologics-inc/dcb996fb-4a71-44fe-87f1-cfe3979d4182

Office: https://www.keypedia.com/offices/office-of-biological-product-operations/7cd31f11-825c-4508-b091-d659fdc63ad9