Form FDA 483 · Issued 2026-02-20
Seniorlife Technologies Inc — FDA Form 483 Analysis
FEI: 3027535342 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Seniorlife Technologies Inc (FEI 3027535342) on 2026-02-20 following an inspection of its manufacturer operations in Washington. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.166(a)(1)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Sample size - test intervals
Inspector Observation Language: "The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability. Specifically, observed during inspection of Seniorlife Technologies Inc on 2026-02-20."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #2 · 21 CFR 211.186(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Written procedures followed
Inspector Observation Language: "Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, observed during inspection of Seniorlife Technologies Inc on 2026-02-20."
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.