# FDA 483 - ADMA Biologics, Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/adma-biologics-inc/84bd853c-69ff-4bd8-897d-4d6b754398e0

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

---

## Details

- Record Type: 483
- Company Name: ADMA Biologics, Inc
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Biotest Pharmaceuticals in Boca Raton, Florida, revealed multiple significant deficiencies across its manufacturing and quality control operations. Key issues included inadequate process and cleaning validations, incomplete investigations into critical deviations, and insufficient control over samples and microbiological media. These findings highlight a need for substantial improvements in the firm's quality systems and adherence to good manufacturing practices.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/adma-biologics-inc/f94a295e-b77d-4b72-959a-36c3f32fd427)
- [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

- [Michael C. Kennedy](https://www.globalkeysolutions.net/people/michael-c-kennedy/3bff77b0-1901-4294-badc-754a94983a13)
- [Cynthia Jim](https://www.globalkeysolutions.net/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)
- [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/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd