BIOMERIEUX, INC. FDA Inspection Record
BIOMERIEUX, INC. is an FDA-registered facility (FEI 1950204) located in HAZELWOOD, MO, US. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Aug 20, 2019: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (1 OAI, 5 VAI, 1 NAI)
- Last OAI inspection
- Jul 30, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Oct 10, 2014
- Recalls as the recalling firm
- 32, latest Jul 24, 2026
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 20, 2019 | Voluntary Action Indicated (VAI) | Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g)) Individual Report of Malfunction (21 CFR 803.50(a)(2)) |
| Jan 25, 2017 | Voluntary Action Indicated (VAI) | Individual Report of Malfunction (21 CFR 803.50(a)(2)) |
| Jun 9, 2015 | Voluntary Action Indicated (VAI) | Sampling plans (21 CFR 820.250(b)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) |
| Jul 30, 2014 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h)) Nonconforming product control (21 CFR 820.90(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 5 more |
| Feb 5, 2013 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Procedures not adequately established or maintained (21 CFR 820.40) Lack of or inadequate procedures (21 CFR 820.100(a)) Design validation - software validation not performed (21 CFR 820.30(g)) and 2 more |
| Nov 14, 2011 | No Action Indicated (NAI) | No citations listed |
| Dec 11, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 24, 2026 | Class II | Z-3231-2026 | VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference… The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a… |
| Jun 4, 2026 | Class II | Z-2715-2026 | VITEK 2 AST-N447 TEST KIT
Product reference 424620 Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch… |
| Jan 5, 2026 | Class II | Z-1236-2026 | VITEK 2 Gram-negative Susceptibility Cards Containing
o Polymyxin B… Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of… |
| Mar 14, 2024 | Class I | Z-1464-2024 | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility)… Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for… |
| Feb 6, 2023 | Class II | Z-1201-2023 | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects… For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been… |
| Nov 9, 2022 | Class II | Z-0783-2023 | API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 and 93 more products As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Dec 20, 2021 | Class II | Z-0525-2022 | API ID 32 C Strips, Reference 32200, Rx Only, IVD
API ID 32 C is a qualitative… Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. |
| Nov 9, 2021 | Class II | Z-0422-2022 | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25… There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT… |
| Jun 24, 2021 | Class II | Z-2226-2021 | ETEST IMIPENEM RELEBACTAM. in vitro diagnostic Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains. |
| Mar 16, 2021 | Class II | Z-1408-2021 | VIDAS¿ CMV IgM 30 Tests bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01). |
Facility details
- Company
- Biomerieux Inc
- Location
- HAZELWOOD, MO (US)
- Source
- device