Form FDA 483 · Issued 2026-02-10
Aurobindo Pharma Limited, Unit VII — FDA Form 483 Analysis
FEI: 3007373532 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Finished Drug Product Manufacturer) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Aurobindo Pharma Limited, Unit VII (FEI 3007373532) on 2026-02-10 following an inspection of its finished drug product manufacturer operations in India. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 212.70(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Conform to specs prior to release
Inspector Observation Language: "You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug product conforms to specifications before final release. Specifically, observed during inspection of Aurobindo Pharma Limited, Unit VII on 2026-02-10."
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 #2 · 21 CFR 314.80(c)(2)(ii)(B)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Late submission of an ICSR
Inspector Observation Language: "You failed to submit an ICSR for the reporting period [within 30 days of the close of the quarter] [within 60 days of the anniversary date of the approval of the application]. Specifically, observed during inspection of Aurobindo Pharma Limited, Unit VII on 2026-02-10."
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 211.28(a)
Personnel GMP Training, Gowning & Hygienic Practices
REPEAT CITATION AT FACILITY
Clothing appropriate for duties performed
Inspector Observation Language: "Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not appropriate for the duties they perform. Specifically, observed during inspection of Aurobindo Pharma Limited, Unit VII on 2026-02-10."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.