Form FDA 483 · Issued 2026-08-28
TAILSTORM HEALTH INC — FDA Form 483 Analysis
FEI: 3015929581 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to TAILSTORM HEALTH INC (FEI 3015929581) on 2026-08-28 following an inspection of its outsourcing facility operations in Arizona. The report documents 3 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.68(b)
Personnel GMP Training, Gowning & Hygienic Practices
REPEAT CITATION AT FACILITY
Computer control of master formula records
Inspector Observation Language: "Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, observed during inspection of TAILSTORM HEALTH INC on 2026-08-28."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #2 · 21 CFR 211.113(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Procedures for sterile drug products
Inspector Observation Language: "Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, observed during inspection of TAILSTORM HEALTH INC on 2026-08-28."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #3 · 21 CFR 211.113(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Validation lacking for sterile drug products
Inspector Observation Language: "Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include [adequate] validation of the [aseptic] [sterilization] process. Specifically, observed during inspection of TAILSTORM HEALTH INC on 2026-08-28."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.