Form FDA 483 · Issued 2026-08-18
Imprimis NJOF LLC — FDA Form 483 Analysis
FEI: 3013024146 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Imprimis NJOF LLC (FEI 3013024146) on 2026-08-18 following an inspection of its outsourcing facility operations in New Jersey. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 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 Imprimis NJOF LLC on 2026-08-18."
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 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 Imprimis NJOF LLC on 2026-08-18."
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.