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Facility Graph → EPA / Specialty Chemical → Gland Chemicals Private Limited
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
EPA / Specialty Chemical FEI: 3008386908 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Gland Chemicals Private Limited

Registered Address: India (India)

For Brand Buyers: Gland Chemicals Private Limited carries a BBB (79/100) rating due to documented FDA activity centered on Incoming Ingredient Identity Testing & COA Qualification. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): FDA ORA FOIA Electronic Reading Room · Resolved Name Aliases: Gland Chemicals Private Limited
BBB
79/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 75th percentile among EPA / Specialty Chemical facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
BBB (79/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
73%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
30%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
6 Brands
~27 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3008386908's FDA Record

5 Questions to Ask Gland Chemicals Private 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 2025-11-27, FDA cited 21 CFR 211.42(c)(1) (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2025-11-27, FDA cited 21 CFR 211.42(c)(2) (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: 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?
  4. Q4: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3008386908?
  5. Q5: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?

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 · 2025-11-27
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Gland Chemicals Private Limited (FEI 3008386908) on 2025-11-27 following an inspection of its producer of regulated products operations in India. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.

  • 21 CFR 211.42(c)(1) (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
  • 21 CFR 211.42(c)(2) (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.

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) 82/100
Materials & Incoming Identity 64/100
Production & Batch Records 81/100
Facilities, Sanitation & Pest 83/100
Laboratory & Stability Controls 80/100
Packaging & Allergen Labeling 84/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (79/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2025-11-27 -8.1 pts INSP-483-3008386908-20251127 ↗
Form 483 (2 observations, 0 repeat) 2025-11-27 -4.8 pts 483-3008386908-20251127 ↗