1Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Inspection Record
Right Value Drug Stores LLC — FDA 483 Findings
Inspectors Nije A ThomasThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Other quality system
Test devices are deficient in that instmments not meeting established specifications are used.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
About this record
Extracted automatically from the document US FDA published on 2026-09-30. 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.
