1Other quality system
Procedures describing sanitizers and sanitizing schedules have not been shown to be effective.
Inspection Record
ADMA Biologics Inc. — FDA 483 Findings
Inspectors Justin A. BoydThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Scientifically sound test procedures have not been established and followed.
3Equipment and facility
Studies have not demonstrated equipment does not alter the quality of drug substances.
4Equipment and facility
Procedures for monitoring and maintenance of facilities and equipment are not adequately followed or established.
5Other quality system
Failure to prevent unauthorized access of changes to data and to provide adequate controls to prevent omissions of data.
6Other quality system
Issuance and use of documents is not controlled.
7Other quality system
Discrepancies were not thoroughly investigated.
8Quality unit oversight
Responsibilities of the quality unit are not in writing.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
