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Bausch & Lomb Incorporated — FDA Facility Profile

FEI 1920664

Bausch & Lomb Incorporated is an FDA-registered facility (FEI 1920664) located in Saint Louis, MO, US. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Oct 8, 2019: No Action Indicated (NAI)
Inspections on record
5 (1 VAI, 4 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
Recalls as the recalling firm
2, latest Aug 8, 2018
Import refusals
2

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
Oct 8, 2019No Action Indicated (NAI)No citations listed
Jun 10, 2016No Action Indicated (NAI)No citations listed
Mar 15, 2013No Action Indicated (NAI)No citations listed
Jun 1, 2012No Action Indicated (NAI)No citations listed
May 17, 2012Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Nonconforming product control (21 CFR 820.90(a))
Investigation of device failures (21 CFR 820.198(c))
Not approved or obsolete document retrieval (21 CFR 820.40(a))
and 4 more

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Aug 8, 2018Class IIZ-3265-2018Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in… and 12 more products
The back cap separates from the body of the vitrectomy cutter.
Nov 4, 2014Class IIZ-0862-2015Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb… and 2 more products
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical…

Facility details

Company
Bausch & Lomb Inc
Location
Saint Louis, MO (US)
Source
device

Import refusals

FDA data resources

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