Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-11-05.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Oct 2024 – 5 Nov 2024 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Nov 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Sangeeta M Khurana, Dawnna D Brown, Mercedes N Overton
5 Nov 2024
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Sangeeta M Khurana, Dawnna D Brown, Mercedes N Overton
5 Nov 2024
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Sangeeta M Khurana, Dawnna D Brown, Mercedes N Overton
5 Nov 2024
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Sangeeta M Khurana, Dawnna D Brown, Mercedes N Overton
5 Nov 2024
21 CFR 211.22(a)
Lack of quality control unit
Cited by Sangeeta M Khurana, Dawnna D Brown, Mercedes N Overton
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SOHM Inc.'s 1 Form 483
Source PDFs 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