Facility

Pfizer Manufacturing Belgium NV

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

Key facts

3recalls · worst Class II

1inspections · 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)	1000654629
Establishment type	Repack or Relabel Medical Device
Location	Rijksweg 12 Puurs-Sint-Amands Antwerpen, BE 2870
Registration status	Active · expires 2026
Parent company	PFIZER INC. (owner-operator 9924008)
Brand names	Genotropin Pen

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Injector, Pen
Product code NSC (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5860

Recalls & enforcement

Class IITerminated2018-10-02
The firm received complaints of the wrap coming apart and leaking granular material
Class IITerminated2016-12-30
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an …
Class IITerminated2016-07-28
Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.

FDA inspections (1)

VAI2023-06-08
Voluntary Action Indicated · Compliance: Devices · citations posted

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. “Pfizer Manufacturing Belgium NV (FEI 1000654629) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000654629-pfizer-manufacturing-belgium-nv/

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