Form FDA 483 · Issued 2026-04-17
Novel Laboratories, Inc. d.b.a Lupin Somerset — FDA Form 483 Analysis
FEI: 3006271438 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Novel Laboratories, Inc. d.b.a Lupin Somerset (FEI 3006271438) on 2026-04-17 following an inspection of its drug manufacturer operations in New Jersey. The report documents 3 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 (3)
Observation #1 · 21 CFR 211.194(a)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Complete test data included in records
Inspector Observation Language: "Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , observed during inspection of Novel Laboratories, Inc. d.b.a Lupin Somerset on 2026-04-17."
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 212.20(e)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Written QA procedures established, followed
Inspector Observation Language: "You did not [establish] [follow] written quality assurance procedures. Specifically,observed during inspection of Novel Laboratories, Inc. d.b.a Lupin Somerset on 2026-04-17."
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 #3 · 21 CFR 211.22(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Authority lacking to review records, investigate errors
Inspector Observation Language: "The quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred]. Specifically, observed during inspection of Novel Laboratories, Inc. d.b.a Lupin Somerset on 2026-04-17."
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.