BLS SYSTEMS, LTD. — FDA Facility Profile

FEI 3000213164

BLS SYSTEMS, LTD. is an FDA-registered facility (FEI 3000213164) located in OAKVILLE Ontario, CA. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Aug 10, 2016: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Aug 10, 2016
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
7

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 10, 2016Official Action Indicated (OAI)Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of or inadequate procedures for labeling (21 CFR 820.120)
Lack of or inadequate DHR procedures (21 CFR 820.184)
and 1 more

Facility details

Company
BLS Systems Ltd
Location
OAKVILLE Ontario (CA)
Source
device

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.