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 → Alabama Center for Reproductive Medicine
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3015364206 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Alabama Center for Reproductive Medicine

Registered Address: Alabama, USA (USA)

For Brand Buyers: Alabama Center for Reproductive Medicine carries a BBB (75/100) 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: Alabama Center for Reproductive Medicine
BBB
75/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 56th 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 (75/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
80%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
55%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
5 Brands
~25 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 3015364206's FDA Record

5 Questions to Ask Alabama Center for Reproductive Medicine 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 2025-09-15, FDA cited 21 CFR 211.84(d)(3) (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 2025-09-15, 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?
  3. Q3: On 2025-09-15, 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?
  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 3015364206?

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 · 2025-09-15
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Alabama Center for Reproductive Medicine (FEI 3015364206) on 2025-09-15 following an inspection of its reproductive tissue operations in Alabama. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Label Control, Undeclared Allergens & Structure/Function Claims.

  • 21 CFR 211.84(d)(3) (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 211.122(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. REPEAT OBSERVATION

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) 78/100
Materials & Incoming Identity 68/100
Production & Batch Records 77/100
Facilities, Sanitation & Pest 79/100
Laboratory & Stability Controls 62/100
Packaging & Allergen Labeling 72/100
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 (75/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2025-09-15 -7.7 pts INSP-483-3015364206-20250915 ↗
Form 483 (3 observations, 1 repeat) 2025-09-15 -9.2 pts 483-3015364206-20250915 ↗