INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs
FEI: 301459503
🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP
Emcure Pharmaceuticals Limited
Registered Address: India (India)
For Brand Buyers: Emcure Pharmaceuticals Limited carries a BB (65/100) rating due to documented FDA activity centered on Master Manufacturing & Batch Production Records (MMR/BPR). Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (2): FDA ORA FOIA Electronic Reading Room, FDA OASIS Import Refusals
· Resolved Name Aliases: Emcure Pharmaceuticals Limited
BB
65/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 13th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
BB (65/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
80%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
42%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
11 Brands
~48 Downstream SKUs
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT
Tailored to FEI 301459503's FDA Record
5 Questions to Ask Emcure Pharmaceuticals Limited Before Signing a Manufacturing Contract
Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:
- Q1: On 2026-05-15, FDA cited 21 CFR 211.188 (Master Manufacturing & Batch Production Records (MMR/BPR)). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q2: On 2026-05-15, FDA cited 21 CFR 211.165(b) (Master Manufacturing & Batch Production Records (MMR/BPR)). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q3: On 2026-05-15, FDA cited 21 CFR 211.166(a) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q4: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
- Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 301459503?
Cross-Database Regulatory & Inspection Timeline
Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.
Form FDA 483 Issued · 2026-05-15
Open Full 483 Analysis & Dossier →
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).
- 21 CFR 211.188 (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
- 21 CFR 211.165(b) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
- 21 CFR 211.166(a) (Finished Product Testing, Stability & Expiration Dating): 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.
- 21 CFR 211.160(a) (Finished Product Testing, Stability & Expiration Dating): 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.
OASIS Border Import Refusal (OASIS-2026-88104) · 2026-05-19
Port: Miami, FL · Charge: DEVICE LACKS 510(K) CLEARANCE (FD&C Act 510(k))
The medical device appears to lack required premarket notification 510(k) clearance or establishment registration.
Manufacturer Right-of-Reply & Free Match Correction
GUARDRAIL PROTECTEDTo ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.
Dimension 3 · FDA 6-System Model
6-Subsystem cGMP Radar Breakdown
Sub-scores mapped across FDA's six core inspection subsystems.
Quality System (CAPA & OOS)
68/100
Materials & Incoming Identity
66/100
Production & Batch Records
51/100
Facilities, Sanitation & Pest
69/100
Laboratory & Stability Controls
50/100
Packaging & Allergen Labeling
70/100
Layer 6 · Clean-Record Sourcing Alternatives
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Score Provenance Receipts
Every point in this facility's FDA Record Index (65/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Inspection Outcome (VAI) | 2026-05-15 | -9.0 pts | INSP-483-301459503-20260515 ↗ |
| Form 483 (4 observations, 0 repeat) | 2026-05-15 | -10.8 pts | 483-301459503-20260515 ↗ |
| Import Refusal (DEVICE LACKS 510(K) CLEARANCE) | 2026-05-19 | -7.2 pts | OASIS-2026-88104 ↗ |