FDA Inspection
Patheon France S.A.S.Patheon France S.A.S. – FDA Inspection, Oct 19, 2018
Record Details
This FDA Inspection record concerns Patheon France S.A.S., with an inspection on October 19, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 19e062d4-9298-495f-bc73-eb2dcc65d715
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069170
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.192No written record of investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Patheon France S.A.S.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 8, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon France S.A.S.
- FDA Inspection 1267774 - 2023-09-29
- FDA Inspection 1135560 - 2019-09-27
- FDA Inspection 1055111 - 2018-06-08
- FDA Inspection 964412 - 2016-03-11
- FDA Inspection 871761 - 2014-03-28
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.