BioReliance Corporation — FDA Facility Profile
BioReliance Corporation is an FDA-inspected facility (FEI 1122041) located in Rockville, MD, US. RegDataLab tracks 11 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Jan 29, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 11 (8 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Jan 5, 2009
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 29, 2026 | Voluntary Action Indicated (VAI) | Study director: follow study protocol (21 CFR 58.33(a)) Study director: unforeseen circumstances (21 CFR 58.33(c)) |
| Nov 22, 2024 | Voluntary Action Indicated (VAI) | Investigations of discrepancies, failures (21 CFR 211.192) |
| Aug 4, 2023 | No Action Indicated (NAI) | No citations listed |
| Jul 13, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 11, 2016 | No Action Indicated (NAI) | No citations listed |
| May 14, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Aug 29, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 3, 2012 | Voluntary Action Indicated (VAI) | input/output verification (21 CFR 211.68(b)) Following/documenting laboratory controls (21 CFR 211.160(a)) Deviations from laboratory control requirements (21 CFR 211.160(a)) Data secured in course of each test (21 CFR 211.194(a)(4)) |
| Oct 28, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 17, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- BioReliance Corporation
- Location
- Rockville, MD (US)
- Source
- inspections