Societal CDMO Gainesville, LLC
Form 483 issued November 19, 2024 · Gainesville, Georgia
- Observations
- 1
- Pages
- 2
- FEI number
- 1035761
In short: On November 19, 2024, FDA issued a Form 483 with 1 observation to Societal CDMO Gainesville, LLC in Gainesville, Georgia (FEI 1035761). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Questions about this 483
What did FDA find at Societal CDMO Gainesville, LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Societal CDMO Gainesville, LLC inspected by FDA?
This Form 483 is dated November 19, 2024.
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.