CC0 PUBLIC RECORD GRAPH Every score & timeline item links directly to its underlying U.S. FDA record (openFDA, ORA FOIA Reading Room, DECRS & OASIS).
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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → BPI Labs, LLC
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3015156709 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

BPI Labs, LLC

Registered Address: Florida, United States (United States)

For Brand Buyers: BPI Labs, LLC carries a BB (67/100) 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: BPI Labs, LLC
BB
67/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 14th 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 (67/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
68%
MODERATE CYCLE WINDOW (6–12 Months)
Dim 5 · 180d WL Escalation
67%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
33 Brands
~141 Downstream SKUs
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VERIFIED CONTRACT MANUFACTURER / CO-PACKER

Co-Packing Capabilities, Minimums & Certifications

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Contract pharmaceuticals & sterile/otc drugs manufacturing in FL.

Minimum Run (MOQ)5,000 units
Typical Turnaround6–10 weeks
In-House Analytical LabYes (FTIR/HPLC/Micro)
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 3015156709's FDA Record

5 Questions to Ask BPI Labs, LLC 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 2026-04-17, FDA cited 21 CFR 211.180(e)(1) (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 2026-04-17, FDA cited 21 CFR 211.22(c) (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: On 2026-04-17, FDA cited 21 CFR 211.137(a) (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?
  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 3015156709?

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 · 2026-04-17
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to BPI Labs, LLC (FEI 3015156709) on 2026-04-17 following an inspection of its outsourcing facility operations in Florida. The report documents 5 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Incoming Ingredient Identity Testing & COA Qualification.

  • 21 CFR 211.180(e)(1) (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 211.22(c) (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 211.137(a) (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 211.84(d)(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 211.68(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems): Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.

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) 70/100
Materials & Incoming Identity 38/100
Production & Batch Records 61/100
Facilities, Sanitation & Pest 63/100
Laboratory & Stability Controls 68/100
Packaging & Allergen Labeling 72/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (67/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-04-17 -8.8 pts INSP-483-3015156709-20260417 ↗
Form 483 (5 observations, 1 repeat) 2026-04-17 -15.9 pts 483-3015156709-20260417 ↗