FDA Inspection
Chiesi USA, Inc.Chiesi USA, Inc. – FDA Inspection, Mar 24, 2010
Record Details
This FDA Inspection record concerns Chiesi USA, Inc., with an inspection on March 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Chiesi USA, Inc.
- Inspection Date
- March 24, 2010
- Product Type
- Drugs
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ID · d7b414fd-b21b-4bd1-9599-6d54f4e1044e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 654681
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
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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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