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# ADMA Biologics FDA-483 Has 8 Observations
- URL: https://www.fdaweb.com/adma-biologics-fda-483-has-8-observations/
- Published: 2018-09-20T12:00:00.000Z
- Updated: 2026-09-15T00:33:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142408

FDA has released the FDA-483 issued following a 4/3-4/12 inspection at ADMA Biologics, Boca Raton, FL. The [document’s](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM620630?ref=fdaweb.com) eight observations were: 

- failing to prevent unauthorized access of changes to data and to provide adequate controls to prevent omissions of data;
- failing to control issuance and use of documents;
- failing to thoroughly investigate discrepancies;
- failing to have written quality unit responsibilities;
- failing to have studies demonstrating that equipment does not alter drug substance quality;
- failing to establish and follow scientifically sound test procedures;
- failing to adequately establish or follow procedures for monitoring and maintenance of facilities and equipment; and
- failing to have procedures describing sanitizers and sanitizing schedules that have been shown to be effective.