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 → Pfizer
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: FEI-59D52EE6 🛡️ LEVEL 0 · PAPER REGISTRATION ONLY

Pfizer

Registered Address: 66 Hudson Blvd, Manhattan, NY (United States)

For Brand Buyers: Pfizer carries a BB (68/100) rating due to documented FDA activity centered on cGMP documentation controls. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): openFDA Enforcement Reports · Resolved Name Aliases: Pfizer
BB
68/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 25th 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 (68/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
81%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
3 Brands
~13 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI FEI-59D52EE6's FDA Record

5 Questions to Ask Pfizer 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: Regarding Recall D-0052-2027 (Class II on 2026-10-28), what line-clearance or preventive control changes were implemented to prevent recurrence?
  2. Q2: Since FDA databases show an electronic registration without a recorded physical FDA inspection, can you provide your most recent third-party SQF, UL, NSF, or ISO cGMP audit report?
  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 FEI-59D52EE6?
  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.

FDA Enforcement Recall (Class II · D-0052-2027) · 2026-10-28
View Recall Notice →
Product: Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.
Reason: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
FDA Enforcement Recall (Class II · D-0051-2027) · 2026-10-28
View Recall Notice →
Product: Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10
Reason: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.

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) 71/100
Materials & Incoming Identity 69/100
Production & Batch Records 70/100
Facilities, Sanitation & Pest 72/100
Laboratory & Stability Controls 69/100
Packaging & Allergen Labeling 73/100
Layer 6 · Clean-Record Sourcing Alternatives

Verified AAA/AA Co-Packers in This Sector

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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 (68/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Recall (Class II) 2026-10-28 -12.0 pts D-0052-2027 ↗
Recall (Class II) 2026-10-28 -12.0 pts D-0051-2027 ↗