Attention www.globalkeysolutions.net is now www.keypedia.com, read the full press release here.
KeyPedia LogoKeyPedia Icon
  1. Home
  2. /
  3. Companies
  4. /
  5. Advanced Accelerator Applications USA, Inc., Millburn, NJ – FDA Inspections
Company
•United States

Advanced Accelerator Applications USA, Inc., Millburn, NJ – FDA Inspections

Inspection records and compliance data for Advanced Accelerator Applications USA, Inc. in Millburn, New Jersey. 7 FDA inspections on record (1 OAI), 2 Form 483s, last inspected August 11, 2026.

Sign in to open in Dashboard
Company Profile

This profile covers Advanced Accelerator Applications USA, Inc. based in Millburn, New Jersey, United States.

FDA Inspection History

FDA inspections
7
OAI
1
VAI
2
NAI
1
Unclassified
3
Form 483s
2
Warning letters
0

First inspected May 17, 2018. Last inspected August 11, 2026.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Calibration/Inspection/Checking not done1 inspection
  • Component written specification1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
August 11, 2026Not classifiedHuman Drugs · Drug Quality Assurance1308280
June 27, 2024VAIHuman Drugs · Drug Quality Assurance1235496
August 25, 2023Not classifiedHuman Drugs1219987
November 3, 2022VAIHuman Drugs · Drug Quality Assurance1187336
November 9, 2021OAIHuman Drugs · Drug Quality Assurance1156330
August 18, 2020NAIHuman Drugs · Drug Quality Assurance1129463
May 17, 2018Not classifiedHuman Drugs1054683
FDA documents

Form 483s (3)

  • Form 483s · June 27, 2024
  • Form 483s · November 3, 2022
  • Form 483s · November 9, 2021

EIRs (5)

  • EIRs · June 27, 2024
  • EIRs · August 25, 2023
  • EIRs · November 3, 2022
  • EIRs · November 9, 2021
  • EIRs · August 18, 2020
People (3)
Daniel Kim
Person
Unnee Ranjan
Person
Robin P. Mathew
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Novartis Manufacturing LLC
Celltrion Inc.
STgen Bio Co., Ltd.
Patheon Biologics Australia Pty Ltd
Alvotech HF
Hugel Inc.
Gland Pharma Limited
Samsung Biologics Co., Ltd.
Shanghai Henlius Biologics Co., Ltd.
Boehringer Ingelheim Fremont, Inc.
Company Information

Name

Advanced Accelerator Applications USA, Inc.

FEI Number

3012484129

Address

57 E Willow St, Millburn, New Jersey 07041, United States

Country

United States

ID: ccfc70b0-8949-4d64-8e92-b725c1f0d81f

KeyPedia
Regulatory Data Transformed
Stay in the loop

KRA score changes, company updates and news. About monthly, unsubscribe anytime.

Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
info@keypedia.com
Quick Links
HomePlatform OverviewMedia
KeyPedia™ Lite
Browse HubDatabase DirectoryRecordsCompaniesOfficesPeopleCareersAbout UsFounding TeamMeet Our ExpertsPartners
Legal & Ethics
Privacy PolicyTerms of ServiceOur Values & MissionCode of Ethics & AI Policy
©2026 KeyPedia™ | Global Key Solutions Corp. All rights reserved.