Bausch Health Companies Inc. — FDA Facility Profile

FEI 3002806613

Bausch Health Companies Inc. is an FDA-registered facility (FEI 3002806613) located in Steinbach, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

Reviewing Bausch Health Companies Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Bausch Health Companies Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection
May 19, 2023: No Action Indicated (NAI)
Inspections on record
6 (6 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
1, latest Oct 28, 2011
Import refusals
10 or more

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
May 19, 2023No Action Indicated (NAI)No citations listed
May 18, 2018No Action Indicated (NAI)No citations listed
Sep 9, 2016No Action Indicated (NAI)No citations listed
May 30, 2014No Action Indicated (NAI)No citations listed
Mar 1, 2012No Action Indicated (NAI)No citations listed
Aug 7, 2009No Action Indicated (NAI)No citations listed

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
Oct 28, 2011Class IIID-1109-2012Wellbutrin XL 150 mg 90 Tablets Rx only Manufactured by Biovail Corporation Mississauga…
Failed USP Dissolution Test Requirement:

Facility details

Company
Bausch Health Companies Inc.
Location
Steinbach (CA)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

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