Societal CDMO Gainesville, LLC
Form 483 issued August 12, 2019 · Gainesville, Georgia
- Inspection
- Aug 5 – Aug 12, 2019
- Investigator
- Veronica Fuentes
- Observations
- 2
- Pages
- 3
- FEI number
- 1035761
In short: On August 12, 2019, FDA issued a Form 483 with 2 observations to Societal CDMO Gainesville, LLC in Gainesville, Georgia (FEI 1035761) after an inspection that ran Aug 5 – Aug 12, 2019. The investigator was Veronica Fuentes. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
The quality control unit lacks authority to fully investigate…
This inspection in context
Veronica Fuentes
22 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmSocietal CDMO Gainesville, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Societal CDMO Gainesville, LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Societal CDMO Gainesville, LLC?
Veronica Fuentes is named on this Form 483, for the inspection of Aug 5 – Aug 12, 2019. Each investigator has a profile showing what they cite most.
When was Societal CDMO Gainesville, LLC inspected by FDA?
The inspection ran Aug 5 – Aug 12, 2019, and the Form 483 is dated August 12, 2019.
How do I get the full Form 483 for Societal CDMO Gainesville, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.