Soaptronic LLC
Form 483 issued February 14, 2020 · LAKE FOREST, California
- Inspection
- Feb 12 – Feb 14, 2020
- Investigators
- Claudia M. Perez-Kasmarski· Lisa Shin· Truong X. Nguyen
- Observations
- 5
- Pages
- 3
- FEI number
- 2027600
In short: On February 14, 2020, FDA issued a Form 483 with 5 observations to Soaptronic LLC in LAKE FOREST, California (FEI 2027600) after an inspection that ran Feb 12 – Feb 14, 2020. The investigators were Claudia M. Perez-Kasmarski, Lisa Shin and Truong X. Nguyen. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The number of qualified personnel is inadequate to perform and supervise the manufacture, processing, packing and…
- 02
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education…
- 03
Drug products failing to meet established…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Claudia M. Perez-Kasmarski
11 documents · 2020–2025
Cites 211.160 (general requirements) 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 211.25(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Soaptronic LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Soaptronic LLC?
Claudia M. Perez-Kasmarski, Lisa Shin and Truong X. Nguyen are named on this Form 483, for the inspection of Feb 12 – Feb 14, 2020. Each investigator has a profile showing what they cite most.
When was Soaptronic LLC inspected by FDA?
The inspection ran Feb 12 – Feb 14, 2020, and the Form 483 is dated February 14, 2020.
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.