Atlas

Form 483

Societal CDMO Gainesville, LLC Form 483, 2019-08-12

FDA issued a Form 483 to Societal CDMO Gainesville, LLC on 2019-08-12 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Societal CDMO Gainesville, LLC · Gainesville, United States · Issued August 12, 2019

Overview

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

Inspectional observations

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

12 Aug 2019
21 CFR 211.194(a)

Complete test data included in records

Cited by Veronica Fuentes

12 Aug 2019
21 CFR 211.22(a)

Authority lacking to review records, investigate errors

Cited by Veronica Fuentes

Inspected site

SCSocietal CDMO Gainesville, LLCGainesville, United States

Inspection team

VFVeronica Fuentes

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 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