FDA Inspection
Soaptronic LLCSoaptronic LLC – FDA Inspection, Feb 14, 2020
Record Details
This FDA Inspection record concerns Soaptronic LLC, with an inspection on February 14, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Soaptronic LLC
- Inspection Date
- February 14, 2020
- Product Type
- Drugs
View Company Profile
ID · 644d8af1-3c44-4aab-adb6-53e537cd2bf7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1118056
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.25(c)Inadequate number of personnel
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Soaptronic LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| June 23, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 28, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Soaptronic LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.