Form FDA 483 · Issued 2025-11-14
TAILSTORM HEALTH INC — FDA Form 483 Analysis
FEI: 3015929581 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to TAILSTORM HEALTH INC (FEI 3015929581) on 2025-11-14 following an inspection of its outsourcing facility operations in Arizona. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.80(d)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Disposition recorded by lot identification
Inspector Observation Language: "The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot. Specifically, observed during inspection of TAILSTORM HEALTH INC on 2025-11-14."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 211.94(c)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Containers & Closures Clean, Sterilized, Pyrogen-free
Inspector Observation Language: "Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use. Specifically, observed during inspection of TAILSTORM HEALTH INC on 2025-11-14."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #3 · 21 CFR 211.180(f)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Responsible firm officials notified in writing
Inspector Observation Language: "Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices]. Specifically, observed during inspection of TAILSTORM HEALTH INC on 2025-11-14."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.