Facility

MADISON POLYMERIC ENGINEERING

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

Key facts

5recalls · 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)	3001451466
Establishment type	Repack or Relabel Medical Device
Location	965 W. MAIN STREET BRANFORD, CT, US 06405
Registration status	Active · expires 2026
Parent company	MADISON POLYMERIC ENGINEERING (owner-operator 9028406)

Activity by year

Recalls (5)
Inspections (3)

Devices registered here (1)

Unit, Drying
Product code JRJ (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2050

Recalls & enforcement

Class IITerminated2019-05-08
This product has been contaminated with Stenotrophomonas lactiubi.
Class IITerminated2018-12-14
The product is contaminated with Pseudomonas.
Class IITerminated2018-03-21
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Class IITerminated2017-11-03
Affected lots may have exceeded its microbial limits.
Class IITerminated2017-04-17
Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.

FDA inspections (3)

NAI2019-02-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-10-03
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-04-12
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. “MADISON POLYMERIC ENGINEERING (FEI 3001451466) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001451466-madison-polymeric-engineering/

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