FDA Inspection
NATURA BISSE INTERNATIONAL SANATURA BISSE INTERNATIONAL SA – FDA Inspection, Jan 29, 2016
Record Details
This FDA Inspection record concerns NATURA BISSE INTERNATIONAL SA, with an inspection on January 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 29, 2016
- Product Type
- Drugs
View Company Profile
ID · a66bce9c-94c4-4b52-bbb6-7fa287d15560
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 960408
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)Written program not followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of NATURA BISSE INTERNATIONAL SA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for NATURA BISSE INTERNATIONAL SA
- FDA Inspection 1180166 - 2022-09-16
- FDA Inspection 820970 - 2013-02-15
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.