# FDA 483 - ADMA Biologics, Inc - August 03, 2021

Source: https://www.globalkeysolutions.net/records/483/adma-biologics-inc/8b5aec1c-3424-460c-8d86-398a3e0fbce4

> FDA 483 for ADMA Biologics, Inc on August 03, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ADMA Biologics, Inc
- Inspection Date: 2021-08-03
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: ADMA Biologics, Inc. in Boca Raton, FL, a licensed biological manufacturer, was cited for four observations during an FDA inspection. The findings included failures in quality control unit procedures, lack of scientific rationale for in-process specifications, inadequate facility maintenance, and deficiencies in the change control procedure. These issues indicate significant concerns regarding the firm's adherence to manufacturing and quality standards for its plasma-derived products.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.globalkeysolutions.net/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

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

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6