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 → Center for Assisted Reproduction
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3003926882 🛡️ LEVEL 3 · INSPECTED & ACCEPTABLE (EMERALD SHIELD)

Center for Assisted Reproduction

Registered Address: Texas, USA (USA)

For Brand Buyers: Center for Assisted Reproduction carries a A (80/100) rating due to documented FDA activity centered on Label Control, Undeclared Allergens & Structure/Function Claims. 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: Center for Assisted Reproduction
A
80/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 73th 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
A (80/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 3 / 4
Physically Inspected by FDA — Acceptable Compliance Posture
Dim 4 · 'Elsa' Audit Odds
69%
MODERATE CYCLE WINDOW (6–12 Months)
Dim 5 · 180d WL Escalation
30%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
8 Brands
~40 Downstream SKUs
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Represent this facility? Claim profile or post 483 closeout response (Free)
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3003926882's FDA Record

5 Questions to Ask Center for Assisted Reproduction 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 2025-09-10, FDA cited 21 CFR 211.122(a) (Label Control, Undeclared Allergens & Structure/Function Claims). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2025-09-10, FDA cited 21 CFR 211.160(b)(3) (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: 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 3003926882?
  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 · 2025-09-10
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Center for Assisted Reproduction (FEI 3003926882) on 2025-09-10 following an inspection of its reproductive human tissue operations in Texas. The report documents 2 inspection observations centered on Label Control, Undeclared Allergens & Structure/Function Claims, Finished Product Testing, Stability & Expiration Dating.

  • 21 CFR 211.122(a) (Label Control, Undeclared Allergens & Structure/Function Claims): Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
  • 21 CFR 211.160(b)(3) (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.

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) 83/100
Materials & Incoming Identity 81/100
Production & Batch Records 82/100
Facilities, Sanitation & Pest 84/100
Laboratory & Stability Controls 73/100
Packaging & Allergen Labeling 77/100
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
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Score Provenance Receipts

Every point in this facility's FDA Record Index (80/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2025-09-10 -7.7 pts INSP-483-3003926882-20250910 ↗
Form 483 (2 observations, 0 repeat) 2025-09-10 -4.6 pts 483-3003926882-20250910 ↗