FDA Inspection
Bausch Health Americas, Inc.Bausch Health Americas, Inc. – FDA Inspection, Jun 26, 2014
Record Details
This FDA Inspection record concerns Bausch Health Americas, Inc., with an inspection on June 26, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bausch Health Americas, Inc.
- Inspection Date
- June 26, 2014
- Product Type
- Devices
View Company Profile
ID · ef2ea89a-d5c4-4f11-9d43-77f5f31992f0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 884972
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
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 |
| July 28, 2015 | 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 930190 - 2015-07-28
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