Company
United StatesChiesi USA, Inc., Cary, NC – FDA Inspections
Inspection records and compliance data for Chiesi USA, Inc. in Cary, North Carolina. 9 FDA inspections on record (1 OAI), last inspected August 26, 2026.
Company Profile
This profile covers Chiesi USA, Inc. based in Cary, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 1
- VAI
- 1
- NAI
- 7
- Form 483s
- 0
- Warning letters
- 0
First inspected April 28, 2009. Last inspected August 26, 2026.
Most cited issue areas
- Control procedures to monitor and validate performance2 inspections
- Complaint Handling Procedure1 inspection
- Contamination, chemical or physical change, deterioration1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 26, 2026 | NAI | · Bioresearch Monitoring | 1334808 |
| August 1, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1247140 |
| June 15, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1062125 |
| March 6, 2015 | NAI | Human Drugs · Bioresearch Monitoring | 918260 |
| March 4, 2015 | NAI | Human Drugs · Drug Quality Assurance | 918223 |
| September 20, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 801466 |
| July 24, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 791772 |
| March 24, 2010 | OAI | Human Drugs · Drug Quality Assurance | 654681 |
| April 28, 2009 | VAI | Human Drugs · Drug Quality Assurance | 615598 |
FDA documents
Other FDA documents (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Chiesi USA, Inc.
FEI Number
3006389494
Address
175 Regency Woods Pl Ste 600, Cary, North Carolina 27518, United States
Country
United States
ID: 1d645906-39bd-4982-85fd-acc725776e8d