Facility

ENCHROMA, INC.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3009455348
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	2001 Addison St Ste 300 Berkeley, CA, US 94704
Registration status	Active · expires 2026
Parent company	EnChroma Inc. (owner-operator 10042442)
Brand names	EnChroma

Activity by year

Recalls (1)

Devices registered here (1)

Lens, Prescription, Color Deficiency
Product code NAI (opens in a new tab) · Class I · Ophthalmic · 21 CFR 886.5844

Recalls & enforcement

Class IIOngoing2024-09-06
Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing a risk of eye injury.

All facilities operated by EnChroma Inc.

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. “ENCHROMA, INC. (FEI 3009455348) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009455348-enchroma-inc/

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