Facility

OMNIA SRL

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3011710821
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Via A. Volta, 7 Mirandola Modena, IT 41037
Registration status	Active · expires 2026
Parent company	Omnia SRL (owner-operator 9059817)
Brand names	Lipoaspirate fat harvest and injection kit

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Suction Lipoplasty System For Removal And Transfer
Product code QUB (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.5040

Recalls & enforcement

Class IITerminated2021-03-30
Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.

FDA inspections (1)

NAI2016-12-15
No 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. “OMNIA SRL (FEI 3011710821) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011710821-omnia-srl/

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