Company
United StatesBausch Health Americas, Inc., Rochester, NY – FDA Inspections
Inspection records and compliance data for Bausch Health Americas, Inc. in Rochester, New York. 6 FDA inspections on record (3 OAI), last inspected September 11, 2024.
Company Profile
This profile covers Bausch Health Americas, Inc. based in Rochester, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 3
- VAI
- 0
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 26, 2014. Last inspected September 11, 2024.
Most cited issue areas
- Training - Lack of or inadequate procedures2 inspections
- Determination not to conduct investigation of complaint1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 11, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1243801 |
| February 2, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1044842 |
| May 10, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1013201 |
| September 1, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 984875 |
| July 28, 2015 | OAI | Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 930190 |
| June 26, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 884972 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bausch Health Americas, Inc.
FEI Number
3009443653
Address
1400 N Goodman St, Rochester, New York 14609, United States
Country
United States
ID: 17e6ac98-da06-497a-932a-26e9a809d2c3