MEDICAL MEASUREMENT SYSTEMS B.V. — FDA Facility Profile
MEDICAL MEASUREMENT SYSTEMS B.V. is an FDA-registered facility (FEI 3002957361) located in HENGELO Overijssel, NL. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Nov 19, 2015: Official Action Indicated (OAI)
- Inspections on record
- 2 (1 OAI, 1 VAI)
- Last OAI inspection
- Nov 19, 2015
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 4
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 19, 2015 | Official Action Indicated (OAI) | DHR - not or inadequately maintained (21 CFR 820.184) Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) and 9 more |
| Nov 8, 2012 | Voluntary Action Indicated (VAI) | DHR - not or inadequately maintained (21 CFR 820.184) Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Investigation of device failures (21 CFR 820.198(c)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) and 6 more |
Facility details
- Company
- Medical Measurement Systems B.V.
- Location
- HENGELO Overijssel (NL)
- Source
- device