DIAGAM S.A. — FDA Facility Profile
DIAGAM S.A. is an FDA-registered facility (FEI 3003749380) located in Ghislenghien Hainaut, BE. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 18, 2025: Official Action Indicated (OAI)
- Inspections on record
- 3 (1 OAI, 1 VAI, 1 NAI)
- Last OAI inspection
- Dec 18, 2025
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 18, 2025 | Official Action Indicated (OAI) | Lack of or inadequate In-process acceptance procedures (21 CFR 820.80(c)) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Equipment Installation, Placement, Specified Requirements (21 CFR 820.70(g)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Jan 12, 2023 | No Action Indicated (NAI) | No citations listed |
| Feb 20, 2020 | Voluntary Action Indicated (VAI) | Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h)) Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Document change records, maintained. (21 CFR 820.40(b)) DHR documentation of label release {see also 820.184} (21 CFR 820.120(b)) and 2 more |
Form 483s and inspection documents
- Dec 18, 2025: 483 on FDA.gov
Facility details
- Company
- DiAgam Societe Anonyme (S.A.)
- Location
- Ghislenghien Hainaut (BE)
- Source
- device