SOHM Inc.
Form 483 issued November 5, 2024 · Vista, California
- Inspection
- Oct 28 – Nov 5, 2024
- Investigator
- Dawnna D. Brown
- Observations
- 9
- Pages
- 12
- FEI number
- 3030149983
In short: On November 5, 2024, FDA issued a Form 483 with 9 observations to SOHM Inc. in Vista, California (FEI 3030149983) after an inspection that ran Oct 28 – Nov 5, 2024. The investigator was Dawnna D. Brown. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
There is no quality…
- 03
Drug product component testing is deficient in that at least one specific test to verify the…
- 04
Deviations from written production and process control…
This inspection in context
Dawnna D. Brown
1 document · 2024
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmSOHM Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SOHM Inc.?
FDA listed 9 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected SOHM Inc.?
Dawnna D. Brown is named on this Form 483, for the inspection of Oct 28 – Nov 5, 2024. Each investigator has a profile showing what they cite most.
When was SOHM Inc. inspected by FDA?
The inspection ran Oct 28 – Nov 5, 2024, and the Form 483 is dated November 5, 2024.
How do I get the full Form 483 for SOHM Inc.?
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.