Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-25.
At a glance
Inspections
8
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jan 2023 – 25 Jan 2023 | Human Drugs | 483 | View 483 → |
| 30 Mar 2021 – 7 Apr 2021 | Human Drugs | 483 | View 483 → |
| 26 Feb 2018 – 13 Mar 2018 | Human Drugs | 483 | View 483 → |
| 31 Aug 2015 – 4 Sep 2015 | Human Drugs | Clean | |
| 11 May 2012 | Not recorded | 483 | View 483 → |
| 21 Oct 2011 | Not recorded | 483 | View 483 → |
| 17 Feb 2011 | Not recorded | 483 | View 483 → |
| 1 Apr 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jan 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Santiago Gallardo Johnson, Rachel C Stanton
25 Jan 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Santiago Gallardo Johnson, Rachel C Stanton
25 Jan 2023
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Santiago Gallardo Johnson, Rachel C Stanton
7 Apr 2021
21 CFR 211.192
No written record of investigation
Cited by Nicholas L Hunt, Santiago Gallardo Johnson
7 Apr 2021
21 CFR 211.192
Quality control unit review of records
Cited by Nicholas L Hunt, Santiago Gallardo Johnson
Investigators
FDA investigators tied to this site in the record.
Santiago Gallardo Johnson2 insp.
Linda Thai2 insp.
Joey V Quitania2 insp.
Virgilio F Pacio2 insp.
Rachel C Stanton1 insp.
Nicholas L Hunt1 insp.
Walden H Lee1 insp.
Christopher M Reed1 insp.
Jai P Singh1 insp.
Djamila Harouaka1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 310.305(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SOCIETAL CDMO SAN DIEGO, LLC's 7 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat