FDA 483 - TAILSTORM HEALTH INC - May 24, 2025

**FDA 483 Summary for Tailstorm Health, Inc.**

**Inspection Details:** - **Company:** Tailstorm Health, Inc. (dba Medivant Healthcare) - **Location:** Chandler, AZ - **Inspection Dates:** May 14, 2025 - May 23, 2025 - **Type of Facility:** Outsourcing facility

**Main Violations/Issues:** 1. **Contamination Control Deficiencies:** The facility"s environmental monitoring during sterile drug filling showed significant nonviable particulate excursions. There was a lack of thorough investigation by the quality unit, and batch records indicated that alert and action limits were set above ISO guidelines.

2. **Inadequate Investigation of Discrepancies:** The firm failed to thoroughly investigate out-of-specification (OOS) results. Investigations lacked complete justification and were not expanded to additional lots when necessary. This issue was noted as a repeat observation.

3. **Quality Control Deficiencies:** Acceptance criteria for sampling and testing were inadequate. The firm did not identify the source of contamination for particles and fibers found during visual inspections, yet released the affected lots without further investigation. This was also a repeat observation.

**Regulatory Framework:** The observations are based on compliance with FDA regulations regarding contamination control, thorough investigation of discrepancies, and adequate quality control measures.

**Required Actions:** - Conduct thorough investigations into environmental monitoring excursions and implement corrective actions. - Ensure complete and justified investigations for all OOS results, expanding to additional lots as needed. - Revise quality control procedures to adequately identify and address contamination sources before releasing products.

The FDA expects Tailstorm Health, Inc. to address these issues promptly to ensure compliance and maintain product safety and efficacy.