Soaptronic LLC FDA Inspection Record
Soaptronic LLC is an FDA-inspected facility (FEI 2027600) located in Lake Forest, CA, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.
Reviewing Soaptronic LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Soaptronic LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
What FDA found at this site
- Latest inspection
- Apr 28, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (6 VAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Dec 12, 2019
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 28, 2025 | Voluntary Action Indicated (VAI) | Training , Education , Experience overall (21 CFR 211.25(a)) Computer control of master formula records (21 CFR 211.68(b)) Absence of Written Procedures (21 CFR 211.100(a)) Actual vs. theoretical yields not determined (21 CFR 211.103) and 6 more |
| Feb 14, 2020 | Voluntary Action Indicated (VAI) | Training , Education , Experience overall (21 CFR 211.25(a)) Inadequate number of personnel (21 CFR 211.25(c)) Computer control of master formula records (21 CFR 211.68(b)) Failing drug products not rejected (21 CFR 211.165(f)) and 1 more |
| Jun 23, 2016 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) GMP Training Frequency (21 CFR 211.25(a)) SOPs not followed / documented (21 CFR 211.100(b)) Scientifically sound laboratory controls (21 CFR 211.160(b)) |
| Oct 21, 2011 | Voluntary Action Indicated (VAI) | Identity Testing of Each Component (21 CFR 211.84(d)(1)) Testing and release for distribution (21 CFR 211.165(a)) Prepared for each batch, include complete information (21 CFR 211.188) |
| Dec 16, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 28, 2010 | Voluntary Action Indicated (VAI) | Training , Education , Experience overall (21 CFR 211.25(a)) Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Equipment Design, Size and Location (21 CFR 211.63) Defined areas of adequate size for operations (21 CFR 211.42(c)) and 12 more |
Facility details
- Company
- Soaptronic LLC
- Location
- Lake Forest, CA (US)
- Source
- inspections