FDA Inspection
Chiesi USA, Inc.Chiesi USA, Inc. – FDA Inspection, Apr 28, 2009
Record Details
This FDA Inspection record concerns Chiesi USA, Inc., with an inspection on April 28, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Chiesi USA, Inc.
- Inspection Date
- April 28, 2009
- Product Type
- Drugs
View Company Profile
ID · c6bdb665-4a21-4d8d-ba31-600649b181e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615598
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Chiesi USA, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2026 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 1, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 15, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 6, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 4, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Chiesi USA, Inc.
- FDA Inspection 1334808 - 2026-08-26
- FDA Inspection 1247140 - 2024-08-01
- FDA Inspection 1062125 - 2018-06-15
- FDA Inspection 918260 - 2015-03-06
- FDA Inspection 918223 - 2015-03-04
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