Facility

Tepha, Incorporated

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)	3005670760
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	99 Hayden Avenue, Suite 360 Lexington, MA, US 02421
Registration status	Active · expires 2026
Parent company	Tepha Inc. (owner-operator 10023049)
Brand names	GalaFLEX LITE

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Surgical Film
Product code OOD (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3300

Recalls & enforcement

Class IITerminated2016-11-21
Endotoxin values from testing of retains slightly exceeded the established specification.

FDA inspections (1)

NAI2022-05-13
No 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.

All facilities operated by Tepha 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. “Tepha, Incorporated (FEI 3005670760) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005670760-tepha-incorporated/

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