Facility

BBI SOLUTIONS OEM LIMITED

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3014684020
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Unit 2 Parkway Crumlin Newport, GB NP11 3EF
Registration status	Active · expires 2026
Parent company	BBI Solutions OEM Limited (owner-operator 10058575)

Activity by year

Recalls (1)

Devices registered here (1)

Campylobacter Spp.
Product code LQP (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3110

Recalls & enforcement

Class IITerminated2016-06-01
A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possible which may incorrectly influence the clinical diagnostic decision.

All facilities operated by BBI Solutions OEM Limited

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. “BBI SOLUTIONS OEM LIMITED (FEI 3014684020) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014684020-bbi-solutions-oem-limited/

Not open yet

Alerts for BBI SOLUTIONS OEM LIMITED

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.