Inspection Record

TAILSTORM HEALTH INC — FDA 483 Findings

US FDAInspected 2025-11-14Published 2025-12-18 3 findingsLaboratory and QC controlsEquipment and facility

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

1Laboratory and QC controls

Established laboratory control mechanisms are not followed.

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.

Other records for this company

2025-05-23 · US FDA · 5 findings2024-10-10 · US FDA · 5 findings2021-07-21 · US FDA · 5 findings
TAILSTORM HEALTH INC findings history — including this company's other documents US FDA documents, 2025 Go to Findings search