FDA Inspection
S.M. Farmaceutici S.r.lS.M. Farmaceutici S.r.l – FDA Inspection, Sep 7, 2018
Record Details
This FDA Inspection record concerns S.M. Farmaceutici S.r.l, with an inspection on September 7, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 93a8f220-5d15-4432-a783-d4e4b5370f9c
Inspection Facts
- Inspection number
- 1064839
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of S.M. Farmaceutici S.r.l
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 28, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for S.M. Farmaceutici S.r.l
- FDA Inspection 1202445 - 2021-10-22
- FDA Inspection 989638 - 2016-07-28
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.