INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs
FEI: 3005587313
🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP
Mylan Laboratories Limited
Registered Address: India (India)
For Brand Buyers: Mylan Laboratories Limited carries a BB (60/100) 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 (2): FDA ORA FOIA Electronic Reading Room, FDA OASIS Import Refusals
· Resolved Name Aliases: Mylan Laboratories Limited
BB
60/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 89% 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
BB (60/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
81%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
67%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
18 Brands
~77 Downstream SKUs
VERIFIED CONTRACT MANUFACTURER / CO-PACKER
Co-Packing Capabilities, Minimums & Certifications
Contract pharmaceuticals & sterile/otc drugs manufacturing in IN.
Minimum Run (MOQ)5,000 units
Typical Turnaround6–10 weeks
In-House Analytical Lab3rd-Party ISO Lab
Turnkey R&D FormulationAvailable
Dosage & Product Formats:
Contract PackagingFormulationBatch Blending
Registrations & Quality Certifications:
FDA Registered Establishment
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT
Tailored to FEI 3005587313's FDA Record
5 Questions to Ask Mylan Laboratories 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 211.142(b) (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?
- Q2: On 2026-05-15, FDA cited 21 CFR 211.84(d)(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?
- Q3: On 2026-05-15, FDA cited 21 CFR 211.67(b)(3) (Cleaning Validation, Sanitation Logs & Pest Control). 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 3005587313?
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 Mylan Laboratories Limited (FEI 3005587313) on 2026-05-15 following an inspection of its finished drug product manufacturer operations in India. The report documents 5 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
- 21 CFR 211.142(b) (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 211.84(d)(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.
- 21 CFR 211.67(b)(3) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
- 21 CFR 211.84(d)(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. REPEAT OBSERVATION
- 21 CFR 211.56(a) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
OASIS Border Import Refusal (OASIS-2026-88105) · 2026-06-19
Port: Los Angeles / Long Beach, CA · Charge: FILTH / INSANITARY CONDITIONS (FD&C Act 402(a)(4))
The article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth.
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)
63/100
Materials & Incoming Identity
31/100
Production & Batch Records
62/100
Facilities, Sanitation & Pest
48/100
Laboratory & Stability Controls
61/100
Packaging & Allergen Labeling
65/100
Layer 6 · Clean-Record Sourcing Alternatives
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Score Provenance Receipts
Every point in this facility's FDA Record Index (60/100) 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-483-3005587313-20260515 ↗ |
| Form 483 (5 observations, 1 repeat) | 2026-05-15 | -16.1 pts | 483-3005587313-20260515 ↗ |
| Import Refusal (FILTH / INSANITARY CONDITIONS) | 2026-06-19 | -7.3 pts | OASIS-2026-88105 ↗ |