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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Loba biotech GmbH
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3002807485 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Loba biotech GmbH

Registered Address: Austria (Austria)

For Brand Buyers: Loba biotech GmbH carries a BBB (74/100) 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 (1): FDA ORA FOIA Electronic Reading Room · Resolved Name Aliases: Loba biotech GmbH
BBB
74/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 54th 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
BBB (74/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
71%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
55%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
9 Brands
~40 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3002807485's FDA Record

5 Questions to Ask Loba biotech GmbH 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 2025-11-11, FDA cited 21 CFR 211.165(c) (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?
  2. Q2: On 2025-11-11, FDA cited 21 CFR 211.182 (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?
  3. Q3: On 2025-11-11, FDA cited 21 CFR 211.188(b)(10) (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 3002807485?

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

FDA Form 483 issued to Loba biotech GmbH (FEI 3002807485) on 2025-11-11 following an inspection of its drug substance manufacturer operations in Austria. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Cleaning Validation, Sanitation Logs & Pest Control.

  • 21 CFR 211.165(c) (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 211.182 (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion. REPEAT OBSERVATION
  • 21 CFR 211.188(b)(10) (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.

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) 77/100
Materials & Incoming Identity 75/100
Production & Batch Records 60/100
Facilities, Sanitation & Pest 64/100
Laboratory & Stability Controls 75/100
Packaging & Allergen Labeling 79/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (74/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2025-11-11 -8.0 pts INSP-483-3002807485-20251111 ↗
Form 483 (3 observations, 1 repeat) 2025-11-11 -9.6 pts 483-3002807485-20251111 ↗