FDA Inspection
Bel Star S.A.Bel Star S.A. – FDA Inspection, Dec 13, 2019
Record Details
This FDA Inspection record concerns Bel Star S.A., with an inspection on December 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bel Star S.A.
- Inspection Date
- December 13, 2019
- Product Type
- Drugs
View Company Profile
ID · 78edd09b-608a-4b8b-b97c-0cd99dd1ef89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1113237
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.52Washing and toilet facilities are deficient
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bel Star S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bel Star S.A.
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.