The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II).

Task Description Request Please post to the ORA Electronic Reading Room
Record Date 04/12/2018
FEI Number 1000525461
Firm Name ADMA Biologics Inc.
Record Type 483
State FL
Establishment Type Manufacturer

Avella of Deer Valley, Inc., Phoenix, AZ, Second Amended 483 Issued 2/

Avella of Deer Valley, Inc., Phoenix, AZ, 483 Issued 2/25/2013

Avella of Deer Valley, Inc., Phoenix, AZ, First Amended 483 Issued 2/2

Record Date 07/31/2015
FEI Number 3006345305
Firm Name Avella of Deer Valley, Inc. dba Avella
Record Type Amended 483
State Arizona
Establishment Type Outsourcing Facility

Record Date 07/29/2015
FEI Number 3006345305
Firm Name Avella of Deer Valley, Inc. dba Avella
Record Type 483
State Arizona
Establishment Type Outsourcing Facility

Avella of Deer Valley, Inc. dba Avella Specialty Pharmacy, Phoenix, AZ. Untitled Letter Issued 02/03/2017

Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page
Record Date 02/03/2017
FEI Number 3006345305
Firm Name Avella of Deer Valley Inc. dba Avella
R

Avella of Deer Valley, Inc. #38, Phoenix, AZ. FMD-145 Letter Issued 08/23/2017

Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page
Record Date 08/23/2017
FEI Number 3012890460
Firm Name Avella of Deer Valley, Inc. #38
Record Type FMD-145
State AZ
Esta

Task Description Request Please post to the 2018 Pharmacy Inspections and Related Records Web page
Record Date 04/19/2018
FEI Number 3006345305
Firm Name Avella of Deer Valley dba Avella Specialty Pharmacy
Record Type 483
State AZ
Establishment Type Outsourcing Facility

Task Description Request Please post to the 2018 Pharmacy Inspections and Related Records Web page
Record Date 04/20/2018
FEI Number 3012890460
Firm Name Avella of Deer Valley, Inc. Store 38
Record Type 483
State AZ
Establishment Type Outsourcing Facility

Task Description Request Please post to the 2018 Pharmacy Inspections and Related Records Web page
Record Date 04/19/2018
FEI Number 3006345305
Firm Name Avella of Deer Valley dba Avella Specialty Pharmacy
Record Type 483
State AZ
Establishment Type Outsourcing Facility

Task Description Request Please post to the 2018 Pharmacy Inspections and Related Records Web page
Record Date 04/25/2018
FEI Number 3006345305
Firm Name Avella of Deer Valley dba Avella Specialty Pharmacy
Record Type 483
State AZ
Establishment Type Outsourcing Facility

Task Description Request Please post to the 2018 Pharmacy Inspections and Related Records Web page
Record Date 08/14/2018
FEI Number 3005247494
Firm Name Avella Specialty Pharmacy (formerly Advanced Pharma Inc.)
Record Type Other Correspondence
State TX
Establishment Type Outsourcing Fac

Abbott Labs, Inc., Sturgis, MI EIR signed 9/26/2008

Abbott Labs, Inc., Sturgis, MI EIR signed 3/24/2010

Abbott Labs, Inc., Sturgis, MI EIR for Inspection Conducted 10/15-10/1

Abbott Labs, Inc., Sturgis, MI EIR signed 2/13/2009

Matrixx Initiatives Inc., Scottsdale, AZ 483 issued 10/19/2009

Matrixx Initiatives Inc. (Zicam), Scottsdale, AZ 483 issued 5/28/2009 (1 page)