CC0 PUBLIC RECORD GRAPH Every score & timeline item links directly to its underlying U.S. FDA record (openFDA, ORA FOIA Reading Room, DECRS & OASIS).
Scoring Formula v2.0 & Legal Guardrails REST API v1
FG
GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Shilpa Medicare Limited
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3018694237 🛡️ LEVEL 1 · ACTIVE REMEDIATION REQUIRED

Shilpa Medicare Limited

Registered Address: India (India)

For Brand Buyers: Shilpa Medicare Limited carries a CCC (23/100) rating due to documented FDA activity centered on Finished Product Testing, Stability & Expiration Dating. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (3): FDA ORA FOIA Electronic Reading Room, FDA Warning Letters Archive, FDA OASIS Import Refusals · Resolved Name Aliases: Shilpa Medicare Limited
CCC
23/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 99% of tracked 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
CCC (23/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 1 / 4
Official Action Indicated (OAI) or Open Warning Letter
Dim 4 · 'Elsa' Audit Odds
89%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
92%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
8 Brands
~33 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3018694237's FDA Record

5 Questions to Ask Shilpa Medicare 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:

  1. Q1: On 2026-05-29, FDA cited 21 CFR 211.58 (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-05-29, 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?
  3. Q3: On 2026-05-29, 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?
  4. 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?
  5. 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 3018694237?

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 · 2026-05-29
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Shilpa Medicare Limited (FEI 3018694237) on 2026-05-29 following an inspection of its drug manufacturer operations in India. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Master Manufacturing & Batch Production Records (MMR/BPR).

  • 21 CFR 211.58 (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
  • 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. REPEAT OBSERVATION
  • 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.
Form FDA 483 Issued · 2025-11-21
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Shilpa Medicare Limited (FEI 3018694237) on 2025-11-21 following an inspection of its drug manufacturer operations in India. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Finished Product Testing, Stability & Expiration Dating.

  • 21 CFR 211.42(c)(4) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
  • 21 CFR 211.122(b) (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.
FDA Warning Letter (CMS-684123) · 2025-12-10
View Warning Letter Details →
CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.58, 21 CFR 211.188) — Status: Open — Awaiting Verified Remediation Closeout

FDA Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.

OASIS Border Import Refusal (OASIS-2026-88101) · 2026-02-19
Port: Newark / NY, NJ · Charge: UNAPPROVED NEW DRUG / UNDECLARED INGREDIENT (FD&C Act 505(a))
The article appears to be a new drug without an approved New Drug Application (NDA) or ANDA.

Manufacturer Right-of-Reply & Free Match Correction

GUARDRAIL PROTECTED

To 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) 25/100
Materials & Incoming Identity 24/100
Production & Batch Records 24/100
Facilities, Sanitation & Pest 27/100
Laboratory & Stability Controls 24/100
Packaging & Allergen Labeling 28/100
Layer 6 · Clean-Record Sourcing Alternatives

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Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (23/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-05-29 -9.0 pts INSP-483-3018694237-20260529 ↗
Inspection Outcome (VAI) 2025-11-21 -8.0 pts INSP-483-3009876430-20251121 ↗
Form 483 (5 observations, 1 repeat) 2026-05-29 -16.3 pts 483-3018694237-20260529 ↗
Form 483 (2 observations, 0 repeat) 2025-11-21 -4.8 pts 483-3009876430-20251121 ↗
Warning Letter (Open) 2025-12-10 -24.4 pts CMS-684123 ↗
Import Refusal (UNAPPROVED NEW DRUG / UNDECLARED INGREDIENT) 2026-02-19 -6.8 pts OASIS-2026-88101 ↗