Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Nov 2024
FDCA 505-1(f)(4)
Failure to comply with REMS Implementation System
Cited by Michael Serrano, Jose A Torres, Meredith L Miller
Inspected site
BHBausch Health US., LLC.Bridgewater, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 505-1(f)(4) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 1 observation
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere