1Other quality system
The use of instruments not meeting established specifications was observed.
Inspection Record
Gilead Sciences, Inc — FDA 483 Findings
Inspectors Carl Lee · Kim Thomas CruseThe 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
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.
3Equipment and facility
Written records of major equipment use are not included in individual equipment logs.
4Laboratory and QC controls
The suitability of all testing methods is not verified under actual conditions o f use.
5Quality unit oversight
The establishment of test procedures including any changes thereto, are not reviewed and approved by the quality control unit.
6Stability and storage
The written stability testing program is not followed.
7Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure c ompliance with established specifications and standards.
8Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials, and labeling conform to appropriate standards of identity, strength, quality an d purity.
9Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
