1Laboratory and QC controls
The sensitivity of test methods have not been.
Inspection Record
Aurobindo Pharm Ltd. Unit 3 — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Deviations from written test procedures are not recorded and justified.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
4Quality unit oversight
The quality control unit lacks authority to fully investigate errors that have occurred.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
6Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
About this record
Extracted automatically from the document US FDA published on 2017-05-02. 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.
