Cenexi - Laboratoires Thissen Sa — FDA Facility Profile
Cenexi - Laboratoires Thissen Sa is an FDA-registered facility (FEI 3007388138) located in BE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 1, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (7 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 1, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 6, 2022 | Voluntary Action Indicated (VAI) | Authority lacking to review records, investigate errors (21 CFR 211.22(a)) Inadequate number of personnel (21 CFR 211.25(c)) Procedures for sterile drug products (21 CFR 211.113(b)) Following/documenting laboratory controls (21 CFR 211.160(a)) and 3 more |
| Feb 19, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 16, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 18, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 4, 2014 | No Action Indicated (NAI) | No citations listed |
| Jul 17, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 11, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Cenexi Laboratoires Thissen SA
- Location
- BE
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
- Source
- decrs