FDA Inspection
Chiesi Farmaceutici S.p.A.Chiesi Farmaceutici S.p.A. – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Chiesi Farmaceutici S.p.A., with an inspection on May 24, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Saleem A. Akhtar
- Scott R. Nichols (Issuing Officer)
View Company Profile
ID · 3c456a9e-bd34-48e0-bb2d-e9a737ac514a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094835
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Chiesi Farmaceutici S.p.A.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | Not classified | Office of Inspections and Investigations | |
| September 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2023 | Not classified | Office of Inspections and Investigations | |
| November 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Chiesi Farmaceutici S.p.A.
- FDA Inspection 1268341 - 2025-03-28
- FDA Inspection 1270425 - 2023-09-29
- FDA Inspection 1215852 - 2023-04-11
- FDA Inspection 1135697 - 2018-11-23
- FDA Inspection 1062323 - 2018-07-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.