Form FDA 483 · Issued 2025-09-16
Lupin Limited — FDA Form 483 Analysis
FEI: 3004819820 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Lupin Limited (FEI 3004819820) on 2025-09-16 following an inspection of its sterile drug manufacturer operations in India. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.170(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Reserve sample quantity - active ingredients only
Inspector Observation Language: "The reserve sample of active ingredient does not consist of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications. Specifically, observed during inspection of Lupin Limited on 2025-09-16."
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 211.110(b)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
In-process materials specifications testing
Inspector Observation Language: "Examination and testing of samples is not done to assure that in-process materials conform to specifications. Specifically, observed during inspection of Lupin Limited on 2025-09-16."
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 211.150(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Recall facilitation
Inspector Observation Language: "A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established. Specifically, observed during inspection of Lupin Limited on 2025-09-16."
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 #4 · 21 CFR 211.160(b)(3)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Drug products - samples representative, identified properly
Inspector Observation Language: "Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified]. Specifically, observed during inspection of Lupin Limited on 2025-09-16."
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 #5 · 21 CFR 211.170(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Reserve drug product sample quantity - all tests
Inspector Observation Language: "The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product. Specifically, observed during inspection of Lupin Limited on 2025-09-16."
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.