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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Perrigo New York, Inc.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 2450054 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Perrigo New York, Inc.

Registered Address: New York, USA (USA)

For Brand Buyers: Perrigo New York, Inc. carries a BB (66/100) rating due to documented FDA activity centered on Cleaning Validation, Sanitation Logs & Pest Control. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (2): FDA ORA FOIA Electronic Reading Room, FDA OASIS Import Refusals · Resolved Name Aliases: Perrigo New York, Inc.
BB
66/100
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 (66/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
73%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
55%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
24 Brands
~96 Downstream SKUs
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Represent this facility? Claim profile or post 483 closeout response (Free)
VERIFIED CONTRACT MANUFACTURER / CO-PACKER

Co-Packing Capabilities, Minimums & Certifications

Request Quote from Perrigo New York, Inc. →

Contract pharmaceuticals & sterile/otc drugs manufacturing in NY.

Minimum Run (MOQ)5,000 units
Typical Turnaround6–10 weeks
In-House Analytical Lab3rd-Party ISO Lab
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 2450054's FDA Record

5 Questions to Ask Perrigo New York, 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 2026-05-08, FDA cited 21 CFR 211.67(b)(3) (Cleaning Validation, Sanitation Logs & Pest Control). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-05-08, FDA cited 21 CFR 211.84(d)(2) (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 2026-05-08, FDA cited 21 CFR 211.56(a) (Cleaning Validation, Sanitation Logs & Pest Control). 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 2450054?

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 · 2026-05-08
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Perrigo New York, Inc. (FEI 2450054) on 2026-05-08 following an inspection of its drug manufacturer operations in New York. The report documents 3 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Incoming Ingredient Identity Testing & COA Qualification.

  • 21 CFR 211.67(b)(3) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
  • 21 CFR 211.84(d)(2) (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 211.56(a) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion. REPEAT OBSERVATION
OASIS Border Import Refusal (OASIS-2026-88109) · 2026-01-19
Port: Miami, FL · Charge: DEVICE LACKS 510(K) CLEARANCE (FD&C Act 510(k))
The medical device appears to lack required premarket notification 510(k) clearance or establishment registration.

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) 69/100
Materials & Incoming Identity 59/100
Production & Batch Records 68/100
Facilities, Sanitation & Pest 48/100
Laboratory & Stability Controls 67/100
Packaging & Allergen Labeling 71/100
Layer 6 · Clean-Record Sourcing Alternatives

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Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (66/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-05-08 -8.9 pts INSP-483-2450054-20260508 ↗
Form 483 (3 observations, 1 repeat) 2026-05-08 -10.7 pts 483-2450054-20260508 ↗
Import Refusal (DEVICE LACKS 510(K) CLEARANCE) 2026-01-19 -6.7 pts OASIS-2026-88109 ↗