FDA Inspection
Cenexi Laboratoires Thissen SACenexi Laboratoires Thissen SA – FDA Inspection, Dec 6, 2022
Record Details
This FDA Inspection record concerns Cenexi Laboratoires Thissen SA, with an inspection on December 6, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 6, 2022
- Product Type
- Drugs
View Company Profile
ID · 7867e076-4add-4400-916f-9b7cad72905b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1192164
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cenexi Laboratoires Thissen SA
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 19, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 4, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cenexi Laboratoires Thissen SA
- FDA Inspection 1250906 - 2023-06-01
- FDA Inspection 1141824 - 2020-02-19
- FDA Inspection 1002425 - 2016-12-16
- FDA Inspection 934545 - 2015-06-18
- FDA Inspection 878521 - 2014-04-04
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.