Soaptronic LLC
FDA inspection history across 2 sites, 2019 to 2025
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one close-out letter; 2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20One close-out letter and one Form 483, at Lake Forest, California and LAKE FOREST, California.
- 2025One Form 483, at LAKE FOREST, California.
- 2025The longest 483 on file: 10 observations over 13 pages at LAKE FOREST, California.
Cited most
Across all Soaptronic observations on file
- 21 CFR 211.25(a)Personnel qualifications3
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.103Calculation of yield1
The complete Soaptronic file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
LAKE FOREST, California
Two Form 483s · 2020 to 2025 · 15 observations
Latest: Form 483, Apr 28, 2025 →Lake Forest, California
One close-out letter · 2019
Latest: Close-out, Dec 12, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-28 | 483 Form 483 | LAKE FOREST, California | 10 | $99 |
| 2020-02-14 | 483 Form 483 | LAKE FOREST, California | 5 | $99 |
| 2019-12-12 | Close-out Close-out letter | Lake Forest, California | — | $99 |
Investigators on these documents
Claudia M. Perez-Kasmarski (1)Darren S. Brown (1)Lisa Shin (1)Navneet Kaur (1)Ngozi G. Offor (1)Truong X. Nguyen (1)
FEI number 2027600 · most recent document Apr 28, 2025
About Soaptronic LLC
How many FDA Form 483s has Soaptronic LLC received?
FDA Intel has 2 Form 483s on file for Soaptronic LLC; the most recent is dated Apr 28, 2025.
When was Soaptronic LLC last inspected by FDA?
The most recent FDA inspection document on file for Soaptronic LLC is a Form 483 dated Apr 28, 2025, for the site in LAKE FOREST, California.
What did FDA cite at Soaptronic LLC?
The regulations cited most in the observations on file for Soaptronic LLC are 21 CFR 211.25(a) (Personnel qualifications), 3 times; 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 2 times.