FDA 483 - TAILSTORM HEALTH INC - November 03, 2025

An FDA inspection of Tailstorm Health Inc dba Medivant Health, an outsourcing facility in Phoenix, AZ, was conducted from November 3 to November 14, 2025. The inspection resulted in a 483 document detailing significant observations related to the company"s laboratory and facility systems, indicating potential non-compliance with drug manufacturing regulations.

Key issues within the laboratory system included a failure to follow established control mechanisms. Specifically, the firm lacked a system suitability procedure and had not performed method suitability testing for the Light Obscuration Particle Count Test used for sterile intravitreal pre-filled syringes, such as bevacizumab. Furthermore, laboratory records were deficient, with no established procedure for reviewing audit trails to ensure analytical data reliability. The Quality unit did not review audit trails, and batch records lacked documentation of these reviews, affecting the release of multiple drug product batches.

Regarding the facilities and equipment system, an observation noted that buildings were not maintained in a clean and sanitary condition. During the filling of bevacizumab on November 11, 2025, an unidentified white string was found on the ceiling of an ISO filling room, posing a potential source of particulate contamination in a critical aseptic processing area.

These observations, issued under the FD&C Act Section 704(b), necessitate a response from Tailstorm Health Inc. The firm is expected to address these findings by discussing any objections or submitting details of corrective actions implemented or planned to ensure compliance with regulatory standards for drug quality and patient safety.