FDA Inspection
Bausch Health Americas, Inc.Bausch Health Americas, Inc. – FDA Inspection, Jul 28, 2015
Record Details
This FDA Inspection record concerns Bausch Health Americas, Inc., with an inspection on July 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bausch Health Americas, Inc.
- Inspection Date
- July 28, 2015
- Product Type
- Devices
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ID · f2ffa03d-620f-439d-a41f-0e8e64efb576
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 930190
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
16- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Showing 10 of 16 citations.
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Other FDA inspections of Bausch Health Americas, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 2, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 10, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 1, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 26, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bausch Health Americas, Inc.
- FDA Inspection 1243801 - 2024-09-11
- FDA Inspection 1044842 - 2018-02-02
- FDA Inspection 1013201 - 2017-05-10
- FDA Inspection 984875 - 2016-09-01
- FDA Inspection 884972 - 2014-06-26
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