Form FDA 483 · Issued 2025-12-14
Empower Clinic Services LLC dba Empower Pharma — FDA Form 483 Analysis
FEI: 3011887629 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Empower Clinic Services LLC dba Empower Pharma (FEI 3011887629) on 2025-12-14 following an inspection of its outsourcing facility operations in Texas. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 212.50(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Written control procedures
Inspector Observation Language: "You did not have written production and process control procedures to [ensure] [document] that [all key process parameters are controlled] [any deviations from the procedures are justified]. Specifically,observed during inspection of Empower Clinic Services LLC dba Empower Pharma on 2025-12-14."
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 #2 · 21 CFR 212.71(b)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Documentation of Non-Conforming Product Investigation
Inspector Observation Language: "You did not document [the results of the investigation] [what happened to the rejected PET drug product] for a PET drug product that did not meet specifications. Specifically, observed during inspection of Empower Clinic Services LLC dba Empower Pharma on 2025-12-14."
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.
Observation #3 · FDCA 501(a)(2)(A)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Non-sterile disinfecting agents, ISO 5 area/classified areas
Inspector Observation Language: "Use of non-sterile [disinfecting agents] [cleaning pads] [cleaning wipes] in the [ISO 5 area] [classified areas]. Specifically, observed during inspection of Empower Clinic Services LLC dba Empower Pharma on 2025-12-14."
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 #4 · FDCA 503B(b)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
All inclusive product report, not submitted
Inspector Observation Language: "Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, observed during inspection of Empower Clinic Services LLC dba Empower Pharma on 2025-12-14."
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.