Micra Biotechnologies Inc — FDA Facility Profile
Micra Biotechnologies Inc is an FDA-registered facility (FEI 1000122226) located in River Edge, NJ, US. Registered operations: ANALYSIS. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 2, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (5 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 2, 2024 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) GMP Training Frequency (21 CFR 211.25(a)) Control / Lab Operations Area (21 CFR 211.42(c)(9)) Following/documenting laboratory controls (21 CFR 211.160(a)) and 1 more |
| Apr 21, 2017 | Voluntary Action Indicated (VAI) | Following/documenting laboratory controls (21 CFR 211.160(a)) |
| Mar 10, 2015 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Following/documenting laboratory controls (21 CFR 211.160(a)) Deviations from laboratory control requirements (21 CFR 211.160(a)) Statement of methods and data (21 CFR 211.194(a)(2)) and 2 more |
| Mar 4, 2013 | Voluntary Action Indicated (VAI) | GMP Training Frequency (21 CFR 211.25(a)) |
| Jan 30, 2012 | Voluntary Action Indicated (VAI) | Training--operations, GMPs, written procedures (21 CFR 211.25(a)) GMP Training Frequency (21 CFR 211.25(a)) |
| Jul 23, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Micra Biotechnologies, Inc.
- Location
- River Edge, NJ (US)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS
- Source
- decrs