Form FDA 483 · Issued 2026-02-27
Brio Pharmaceuticals Inc — FDA Form 483 Analysis
FEI: 1628196 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Prescription Drug Manufacturer) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Brio Pharmaceuticals Inc (FEI 1628196) on 2026-02-27 following an inspection of its prescription drug manufacturer operations in Texas. The report documents 4 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.180(e)(2)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Review of problem drugs
Inspector Observation Language: "The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation] records for each drug product. Specifically, observed during inspection of Brio Pharmaceuticals Inc on 2026-02-27."
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.
Observation #2 · 21 CFR 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Establishment of calibration procedures
Inspector Observation Language: "Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed]. Specifically, observed during inspection of Brio Pharmaceuticals Inc on 2026-02-27."
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 #3 · 21 CFR 211.194(a)(1)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Sample identification and other information
Inspector Observation Language: "Laboratory records do not include [a description of the sample received for testing] [the source or location from where the sample was obtained] [the quantity of the sample] [the lot number or other distinctive code of the sample] [the date the sample was taken] [the date the sample was received for testing]. Specifically, observed during inspection of Brio Pharmaceuticals Inc on 2026-02-27."
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 #4 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Exposed to lower quality air/ISO 5
Inspector Observation Language: "[Sterile drugs] [Materials] were exposed to lower than ISO 5 quality air. Specifically, observed during inspection of Brio Pharmaceuticals Inc on 2026-02-27."
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.