Facility

West Pharmaceutical Services AZ, Inc.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3001155023
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	14677 NORTH 74TH ST. SCOTTSDALE, AZ, US 85260
Registration status	Active · expires 2026
Parent company	WEST PHARMACEUTICAL SERVICES, INC. (owner-operator 2514921)
Brand names	SmartDose

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

On-Body Injector
Product code QLF (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5860

Recalls & enforcement

Class IIOngoing2024-09-24
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.

FDA inspections (3)

NAI2023-08-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2022-08-19
Voluntary Action Indicated · Compliance: Devices
NAI2019-08-27
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “West Pharmaceutical Services AZ, Inc. (FEI 3001155023) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001155023-west-pharmaceutical-services-az-inc/

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