The Binding Site Group Ltd. FDA Inspection Record
The Binding Site Group Ltd. is an FDA-registered facility (FEI 3002808340) located in BIRMINGHAM, GB. RegDataLab tracks 1 FDA inspection at this facility.
What FDA found at this site
- Latest inspection
- Sep 29, 2011: 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
- 23, latest Apr 16, 2026
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 29, 2011 | Voluntary Action Indicated (VAI) | Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) DMR - not or inadequately maintained (21 CFR 820.181) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Apr 16, 2026 | Class II | Z-2362-2026 | Brand Name: EXENT Analyser
Product Name: EXENT Analyser
Model/Catalog Number… It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite… |
| Oct 15, 2021 | Class II | Z-0274-2022 | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S
Freelite Human Lambda… Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between… |
| May 20, 2021 | Class II | Z-2030-2021 | FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie… The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. |
| Nov 18, 2020 | Class II | Z-0943-2021 | Optilite Freelite Mx Kappa Free Kit
REF LK016.M.OPT.A Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias… |
| Apr 9, 2020 | Class II | Z-2071-2020 | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176… A software issue that may affect the analyzer's result accuracy. |
| Nov 6, 2019 | Class II | Z-1500-2020 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code… It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This… |
| Oct 7, 2019 | Class II | Z-2110-2020 | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI… Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid… |
| Jul 29, 2019 | Class II | Z-1327-2020 | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values… |
| Apr 25, 2019 | Class II | Z-1619-2020 | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI… A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L… |
| Feb 19, 2019 | Class II | Z-0671-2020 | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent… Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits |
FDA record score
19 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.
23 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-2362-2026, this FEI as the recalling firm | Apr 16, 2026 | 4 x 1 | 4 |
| Class II recall Z-0274-2022, this FEI as the recalling firm | Oct 15, 2021 | 4 x 0.25 | 1 |
| Class II recall Z-2030-2021, this FEI as the recalling firm | May 20, 2021 | 4 x 0.25 | 1 |
| Class II recall Z-0943-2021, this FEI as the recalling firm | Nov 18, 2020 | 4 x 0.25 | 1 |
| Class II recall Z-2071-2020, this FEI as the recalling firm | Apr 9, 2020 | 4 x 0.25 | 1 |
| Class II recall Z-1500-2020, this FEI as the recalling firm | Nov 6, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-2110-2020, this FEI as the recalling firm | Oct 7, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-1327-2020, this FEI as the recalling firm | Jul 29, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-1619-2020, this FEI as the recalling firm | Apr 25, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-0671-2020, this FEI as the recalling firm | Feb 19, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-0604-2019, this FEI as the recalling firm | Nov 6, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-1469-2020, this FEI as the recalling firm | Aug 12, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-0477-2019, this FEI as the recalling firm | Jul 25, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-1301-2018, this FEI as the recalling firm | Mar 9, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-0553-2018, this FEI as the recalling firm | Jan 4, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-0002-2018, this FEI as the recalling firm | Aug 23, 2017 | 4 x 0.25 | 1 |
| Class II recall Z-1053-2017, this FEI as the recalling firm | Oct 28, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1043-2017, this FEI as the recalling firm | Jul 5, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1018-2017, this FEI as the recalling firm | May 13, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1067-2017, this FEI as the recalling firm | Sep 11, 2014 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1050-2017, this FEI as the recalling firm | Nov 28, 2012 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1055-2017, this FEI as the recalling firm | Oct 9, 2012 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 29, 2011 | 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
- The Binding Site Group, Ltd.
- Location
- BIRMINGHAM (GB)
- Source
- device