BION ENTERPRISES, LTD.
1 recall(s) on record — most severe on record: Class III.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Antiserum, Fluorescent, RubeolaProduct code GRE (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3520
Recalls & enforcement
- Class IIITerminated2013-01-23Affected products have a labeled expiration date of one year too long.
FDA inspections (1)
- VAI2016-11-18Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “BION ENTERPRISES, LTD. (FEI 1419968) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1419968-bion-enterprises-ltd/
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