Societal CDMO San Diego, LLC
Form 483 issued January 25, 2023 · San Diego, California
- Inspection
- Jan 17 – Jan 25, 2023
- Investigators
- Rachel C. Stanton· Santiago Gallardo Johnson
- Observations
- 3
- Pages
- 4
- FEI number
- 3003600362
In short: On January 25, 2023, FDA issued a Form 483 with 3 observations to Societal CDMO San Diego, LLC in San Diego, California (FEI 3003600362) after an inspection that ran Jan 17 – Jan 25, 2023. The investigators were Rachel C. Stanton and Santiago Gallardo Johnson. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Rachel C. Stanton
5 documents · 2022–2024
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmSocietal CDMO San Diego, 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Societal CDMO San Diego, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Societal CDMO San Diego, LLC?
Rachel C. Stanton and Santiago Gallardo Johnson are named on this Form 483, for the inspection of Jan 17 – Jan 25, 2023. Each investigator has a profile showing what they cite most.
When was Societal CDMO San Diego, LLC inspected by FDA?
The inspection ran Jan 17 – Jan 25, 2023, and the Form 483 is dated January 25, 2023.
How do I get the full Form 483 for Societal CDMO San Diego, 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.