Form FDA 483 · Issued 2025-11-21
Lupin Limited — FDA Form 483 Analysis
FEI: 3004819820 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Manufacturer) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Lupin Limited (FEI 3004819820) on 2025-11-21 following an inspection of its drug manufacturer operations in India. The report documents 3 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.42(c)(7)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Quarantined Drug Products Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release. Specifically, observed during inspection of Lupin Limited on 2025-11-21."
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 211.130(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Lot or control number assigned
Inspector Observation Language: "The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch. Specifically, observed during inspection of Lupin Limited on 2025-11-21."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #3 · 21 CFR 211.134(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Correct labels during finishing operations
Inspector Observation Language: "Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. Specifically, observed during inspection of Lupin Limited on 2025-11-21."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.