Form FDA 483 · Issued 2026-05-15
Emcure Pharmaceuticals Limited — FDA Form 483 Analysis
FEI: 301459503 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: David K. Chen
FDA Form 483 issued to Emcure Pharmaceuticals Limited (FEI 301459503) on 2026-05-15 following an inspection of its manufacturer operations in India. The report documents 4 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.188
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Prepared for each batch, include complete information
Inspector Observation Language: "Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch]. Specifically, observed during inspection of Emcure Pharmaceuticals Limited on 2026-05-15."
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 211.165(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Microbiological testing
Inspector Observation Language: "Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, observed during inspection of Emcure Pharmaceuticals Limited on 2026-05-15."
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 211.166(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Written program not followed
Inspector Observation Language: "The written stability testing program is not followed. Specifically, observed during inspection of Emcure Pharmaceuticals Limited on 2026-05-15."
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 #4 · 21 CFR 211.160(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
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 Emcure Pharmaceuticals Limited on 2026-05-15."
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.