FDA Inspection
Bausch Health Companies Inc.Bausch Health Companies Inc. – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns Bausch Health Companies Inc., with an inspection on April 26, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 1370a46a-7475-4bc7-aeec-1a1d3c8cf563
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089615
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Bausch Health Companies Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 17, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bausch Health Companies Inc.
- FDA Inspection 1229765 - 2024-01-19
- FDA Inspection 1190487 - 2022-09-29
- FDA Inspection 1108379 - 2019-09-19
- FDA Inspection 1007199 - 2017-02-17
- FDA Inspection 914426 - 2015-02-20
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