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 → Bora Pharmaceuticals Injectables Inc
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 1000512361 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Bora Pharmaceuticals Injectables Inc

Registered Address: Maryland, USA (USA)

For Brand Buyers: Bora Pharmaceuticals Injectables Inc carries a BBB (73/100) 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: Bora Pharmaceuticals Injectables Inc
BBB
73/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 50th 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 (73/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
79%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
55%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
7 Brands
~29 Downstream SKUs
🛡️ Run AI Mock Inspection on This Plant ⚖️ Compare Side-by-Side vs. Clean Co-Packers 📄 Request EIR via FOIA
Represent this facility? Claim profile or post 483 closeout response (Free)
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 1000512361's FDA Record

5 Questions to Ask Bora Pharmaceuticals Injectables Inc 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 2026-03-20, FDA cited 21 CFR 211.22(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?
  2. Q2: On 2026-03-20, FDA cited 21 CFR 211.160(a) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2026-03-20, FDA cited 21 CFR 211.68(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems). 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 1000512361?

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 · 2026-03-20
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Bora Pharmaceuticals Injectables Inc (FEI 1000512361) on 2026-03-20 following an inspection of its sterile drug manufacturer operations in Maryland. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Finished Product Testing, Stability & Expiration Dating.

  • 21 CFR 211.22(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.
  • 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. REPEAT OBSERVATION
  • 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) 76/100
Materials & Incoming Identity 66/100
Production & Batch Records 75/100
Facilities, Sanitation & Pest 69/100
Laboratory & Stability Controls 60/100
Packaging & Allergen Labeling 78/100
Layer 6 · Clean-Record Sourcing Alternatives

Verified AAA/AA Co-Packers in This Sector

Compare or request quotes from top-rated contract manufacturers with clean FDA inspection histories:

Lone Star Nutraceuticals & Gummy Works LLC (TX)
Grade AAA · 99/100 Clean Record
Get Quote →
Get Quote →
Get Quote →

Score Provenance Receipts

Every point in this facility's FDA Record Index (73/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-03-20 -8.7 pts INSP-483-1000512361-20260320 ↗
Form 483 (3 observations, 1 repeat) 2026-03-20 -10.4 pts 483-1000512361-20260320 ↗