Facility

BELLUS MEDICAL, LLC

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

Key facts

1recalls · worst Class II

2inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010392991
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	207 Mockingbird Ln Johnson City, TN, US 37604
Registration status	Active · expires 2026
Parent company	Bellus Medical, LLC (owner-operator 10044925)
Brand names	SkinPen Precision System

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Powered Microneedle Device
Product code QAI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4430

Recalls & enforcement

Class IITerminated2019-01-18
Cosmetic Kit was packaged with a mislabel medical product.

FDA inspections (2)

NAI2018-07-25
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
OAI2016-03-23
Official Action Indicated · Compliance: Devices

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.

FDA warning letters (1)

Warning Letter2016-09-13
Warning Letter (opens in a new tab) · Johnson City Tennessee

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Bellus Medical, LLC

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. “BELLUS MEDICAL, LLC (FEI 3010392991) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010392991-bellus-medical-llc/

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