MILLIPORE (UK) LTD FDA Inspection Record
MILLIPORE (UK) LTD is an FDA-registered facility (FEI 3002638287) located in LIVINGSTON, W. LOTHIAN West Lothian, GB. RegDataLab tracks 7 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Feb 27, 2020: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (6 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
- Recalls as the recalling firm
- 1, latest Nov 20, 2012
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 27, 2020 | Voluntary Action Indicated (VAI) | Maintenance - tracing (21 CFR 600.12(a)) Tests prior to release (21 CFR 610.1) |
| Feb 26, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 2, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 4, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 22, 2011 | No Action Indicated (NAI) | No citations listed |
| Jun 30, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 24, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 20, 2012 | Class III | B-0725-13 | Blood Grouping Reagent, Anti-e (Human Monoclonal)(IgM)(For Further Manufacturing Use)
EMD… Single lot of Blood Grouping Reagent For Further Manufacturing Use, with a stability test point failure, was distributed. |
FDA record score
3 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
6 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Feb 27, 2020 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Feb 26, 2018 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Oct 2, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Oct 4, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jun 30, 2011 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 24, 2009 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Millipore (U.K.) Ltd.
- Location
- LIVINGSTON, W. LOTHIAN West Lothian (GB)
- Source
- device