Societal CDMO San Diego, LLC
Form 483 issued April 7, 2021 · San Diego, California
- Inspection
- Mar 30 – Apr 7, 2021
- Investigators
- Nicholas L. Hunt· Santiago Gallardo Johnson
- Observations
- 5
- Pages
- 8
- FEI number
- 3003600362
In short: On April 7, 2021, FDA issued a Form 483 with 5 observations to Societal CDMO San Diego, LLC in San Diego, California (FEI 3003600362) after an inspection that ran Mar 30 – Apr 7, 2021. The investigators were Nicholas L. Hunt and Santiago Gallardo Johnson. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.192 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 02
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
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 5 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Societal CDMO San Diego, LLC?
Nicholas L. Hunt and Santiago Gallardo Johnson are named on this Form 483, for the inspection of Mar 30 – Apr 7, 2021. Each investigator has a profile showing what they cite most.
When was Societal CDMO San Diego, LLC inspected by FDA?
The inspection ran Mar 30 – Apr 7, 2021, and the Form 483 is dated April 7, 2021.
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.