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Form 483

SOCIETAL CDMO SAN DIEGO, LLC Form 483, 2023-01-25

FDA issued a Form 483 to SOCIETAL CDMO SAN DIEGO, LLC on 2023-01-25 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

SOCIETAL CDMO SAN DIEGO, LLC · San Diego, United States · Issued January 25, 2023

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

25 Jan 2023
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Santiago Gallardo Johnson, Rachel C Stanton

25 Jan 2023
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Santiago Gallardo Johnson, Rachel C Stanton

25 Jan 2023
21 CFR 211.42(a)

Buildings of Suitable Size, Construction, Location

Cited by Santiago Gallardo Johnson, Rachel C Stanton

Inspected site

SCSOCIETAL CDMO SAN DIEGO, LLCSan Diego, United States

Inspection team

SGSantiago Gallardo Johnson
RCRachel C Stanton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

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