FDA Inspection
Neotron S.p.ANeotron S.p.A – FDA Inspection, Sep 6, 2019
Record Details
This FDA Inspection record concerns Neotron S.p.A, with an inspection on September 6, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · c144e741-6f86-4d70-9ee6-b5cc20653c3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101319
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Neotron S.p.A
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 7, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Neotron S.p.A
- FDA Inspection 1276129 - 2023-02-23
- FDA Inspection 1022356 - 2017-07-07
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.