Form FDA 483 · Issued 2025-11-14
Empower Clinic Services LLC dba Empower Pharma — FDA Form 483 Analysis
FEI: 3011887629 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile and Non Sterile Drug Products) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Empower Clinic Services LLC dba Empower Pharmacy (FEI 3011887629) on 2025-11-14 following an inspection of its producer of sterile and non sterile drug products operations in Texas. 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 211.137(b)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Storage conditions
Inspector Observation Language: "Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies. Specifically, observed during inspection of Empower Clinic Services LLC dba Empower Pharmacy on 2025-11-14."
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 211.94(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Protection from external factors
Inspector Observation Language: "Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. Specifically, observed during inspection of Empower Clinic Services LLC dba Empower Pharmacy on 2025-11-14."
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.