RANDOX LABORATORIES, LTD. FDA Inspection Record
RANDOX LABORATORIES, LTD. is an FDA-inspected facility (FEI 3006697287) located in Crumlin, GB. RegDataLab tracks 1 FDA inspection at this facility.
What FDA found at this site
- Latest inspection
- Apr 28, 2016: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- 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
- 3, latest Jul 30, 2020
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 28, 2016 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 30, 2020 | Class II | Z-2965-2020 | AM1015 Randox Ammonia (NH3), Enzymatic UV Method
For the quantitative in vitro… and 1 more product Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. |
| Jul 10, 2020 | Class II | Z-2923-2020 | Amylase AY3805 batch 480449
Amylase Ethylidene Blocked-pNPG7 Reagent and 1 more product Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on… |
| Jun 26, 2020 | Class II | Z-2751-2020 | Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is… and 2 more products Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. |
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.
4 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-2965-2020, this FEI as the recalling firm | Jul 30, 2020 | 4 x 0.25 | 1 |
| Class II recall Z-2923-2020, this FEI as the recalling firm | Jul 10, 2020 | 4 x 0.25 | 1 |
| Class II recall Z-2751-2020, this FEI as the recalling firm | Jun 26, 2020 | 4 x 0.25 | 1 |
| Inspection classified VAI | Apr 28, 2016 | 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 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 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 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- RANDOX LABORATORIES, LTD.
- Location
- Crumlin (GB)
- Source
- inspections