Soaptronic LLC
Form 483 issued April 28, 2025 · LAKE FOREST, California
- Inspection
- Apr 22 – Apr 28, 2025
- Investigators
- Darren S. Brown· Navneet Kaur· Ngozi G. Offor
- Observations
- 10
- Pages
- 13
- FEI number
- 2027600
In short: On April 28, 2025, FDA issued a Form 483 with 10 observations to Soaptronic LLC in LAKE FOREST, California (FEI 2027600) after an inspection that ran Apr 22 – Apr 28, 2025. The investigators were Darren S. Brown, Navneet Kaur and Ngozi G. Offor. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
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
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmSoaptronic LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Soaptronic LLC?
FDA listed 10 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Soaptronic LLC?
Darren S. Brown, Navneet Kaur and Ngozi G. Offor are named on this Form 483, for the inspection of Apr 22 – Apr 28, 2025. Each investigator has a profile showing what they cite most.
When was Soaptronic LLC inspected by FDA?
The inspection ran Apr 22 – Apr 28, 2025, and the Form 483 is dated April 28, 2025.
How do I get the full Form 483 for Soaptronic 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.