FDA Inspection 654681 — Chiesi USA, Inc.
The FDA completed an inspection of Chiesi USA, Inc. on March 24, 2010 in Cary, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 24, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cary, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |