Form 483

Scilex Pharmaceuticals Inc. Form 483, 2026-05-20

FDA issued a Form 483 to Scilex Pharmaceuticals Inc. on 2026-05-20 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Scilex Pharmaceuticals Inc. · Palo Alto, United States · Issued May 20, 2026

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

20 May 2026
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Kristin M Abaonza

Inspected site

SPScilex Pharmaceuticals Inc.Palo Alto, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x

Full 483 report

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The full inspection record, as Atlas holds it, 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