Form FDA 483 · Issued 2026-05-05
Zydus Lifesciences Limited — FDA Form 483 Analysis
FEI: 3012977526 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Zydus Lifesciences Limited (FEI 3012977526) on 2026-05-05 following an inspection of its sterile manufacturer operations in India. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.160(a)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Following/documenting laboratory controls
Inspector Observation Language: "Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, observed during inspection of Zydus Lifesciences Limited on 2026-05-05."
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 211.188(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Batch production and Batch Control Record Requirements
Inspector Observation Language: "The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding]. Specifically, observed during inspection of Zydus Lifesciences Limited on 2026-05-05."
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 211.198(a)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Complaint Handling Procedure
Inspector Observation Language: "Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed]. Specifically, observed during inspection of Zydus Lifesciences Limited on 2026-05-05."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #4 · 21 CFR 211.25(a)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
GMP Training Frequency
Inspector Observation Language: "GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them. Specifically, observed during inspection of Zydus Lifesciences Limited on 2026-05-05."
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.
Observation #5 · 21 CFR 211.42(a)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Buildings of Suitable Size, Construction, Location
Inspector Observation Language: "Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations. Specifically, observed during inspection of Zydus Lifesciences Limited on 2026-05-05."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.