Facility

DRG International, Inc.

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

Key facts

1recalls · 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)	2245285
Establishment type	Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device
Location	841 Mountain Ave Springfield, NJ, US 07081
Registration status	Active · expires 2026
Parent company	BIOCHECK, INC. (owner-operator 9033543)
Brand names	ANCA Screen IgG ELISA, Proteinase-3 IgG ELISA

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Product code MOB (opens in a new tab) · Class II · Immunology · 21 CFR 866.5660

Recalls & enforcement

Class IITerminated2021-10-14
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

FDA inspections (1)

VAI2019-04-15
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: 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. “DRG International, Inc. (FEI 2245285) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2245285-drg-international-inc/

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