1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Inspection Record
Right Value Drug Stores, LLC — FDA 483 Findings
Inspectors Demario L Walls · Milton J DeJesus TavarezThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
3Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
4Process validation
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
5Documentation and records
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
About this record
Extracted automatically from the document US FDA published on 2025-08-11. 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.
