RICHARD-ALLAN SCIENTIFIC LLC FDA Inspection Record
RICHARD-ALLAN SCIENTIFIC LLC is an FDA-registered facility (FEI 1831638) located in KALAMAZOO, MI, US. RegDataLab tracks 2 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Apr 23, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 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
- 7, latest Jun 4, 2018
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 23, 2025 | Voluntary Action Indicated (VAI) | Sampling plans (21 CFR 820.250(b)) Process changes - review, evaluation and revalidation (21 CFR 820.75(c)) Individual Report of Malfunction (21 CFR 803.50(a)(2)) |
| Aug 26, 2015 | No Action Indicated (NAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 4, 2018 | Class III | Z-2749-2018 | EZ Single Cytofunnel Brown, A78710004
Product Usage:
The EZ Single Cytofunnel with… Mislabeled product |
| Mar 15, 2017 | Class II | Z-1895-2017 | Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700
Shandon Rapid Chrome Kwik-Diff… Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead. |
| Jun 13, 2016 | Class II | Z-2351-2016 | Richard Allan Scientific 10% Neutral Buffered Formalin,
Part Number: 53901 and… potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the… |
| Feb 16, 2016 | Class III | Z-1319-2016 | Richard-Allan Scientific Paraffin Type 3
For in vitro diagnostic use. For use as an… Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box… |
| Apr 29, 2015 | Class II | Z-1639-2015 | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l
Product Usage:
A mucoliquefying… and 1 more product Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab… |
| Feb 19, 2015 | Class III | Z-1264-2015 | Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1… The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label… |
| Sep 17, 2014 | Class I | Z-0012-2015 | Protocol 10% NBF
Product Usage: 10% NBF is used to store and fixate tissue prior to… and 6 more products The affected lots could have NBF concentrations that are lower or higher than the desired specifications. |
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
- Richard-Allan Scientific Company
- Location
- KALAMAZOO, MI (US)
- Source
- device