1Equipment and facility
Routine inspection and checking of equipment is not performed according to a written program designed to assure proper performance.
Inspection Record
TAILSTORM HEALTH INC — FDA 483 Findings
Inspectors Ronda R Loyd Jones · Nicholas L HuntThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
3Equipment and facility
Buildings used in the manufacturing, processing and packing of a drug product are not maintained in a good state of repair.
4Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2025-08-07. 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.
