# FDA 483 - ADMA Biologics, Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/adma-biologics-inc/f94a295e-b77d-4b72-959a-36c3f32fd427

> FDA 483 for ADMA Biologics, Inc on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ADMA Biologics, Inc
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of ADMA Biologics Inc. in Boca Raton, FL, revealed significant deficiencies across multiple areas, including data integrity, document control, investigation processes, quality unit responsibilities, equipment qualification, test procedures, facility maintenance, and sanitization effectiveness. These issues indicate a systemic lack of adequate controls and adherence to established procedures, posing potential risks to product quality and patient safety. The report highlights repeat observations, suggesting persistent non-compliance.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/adma-biologics-inc/84bd853c-69ff-4bd8-897d-4d6b754398e0)
- [483 - 2018-04-12](https://www.globalkeysolutions.net/records/483/adma-biologics-inc/7e6697ae-e4d9-46bc-85b0-816179d3ad68)
- [483 - 2021-08-03](https://www.globalkeysolutions.net/records/483/adma-biologics-inc/8b5aec1c-3424-460c-8d86-398a3e0fbce4)
- [483 - 2024-12-11](https://www.globalkeysolutions.net/records/483/adma-biologics-inc/d5a0d911-2d27-49c0-8335-a6f11c190d27)

## Related Officers

- [Justin A. Boyd, Investigator](https://www.globalkeysolutions.net/people/justin-a-boyd-investigator/db1000e7-021c-4af3-b45d-8b5d4eefe925)
- [Michele L. Forster, PhD, Investigator](https://www.globalkeysolutions.net/people/michele-l-forster-phd-investigator/aa148983-2b26-4359-9097-ab0d7066ab93)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1