1Laboratory and QC controls
Established laboratory control mechanisms are not followed.
Inspection Record
TAILSTORM HEALTH INC — FDA 483 Findings
Inspectors Cecilia H KieuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
3Laboratory and QC controls
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
About this record
Extracted automatically from the document US FDA published on 2025-12-18. 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.
