Seriously Clean, Ltd
Form 483 issued March 11, 2026 · Nixa, Missouri
- Inspection
- Mar 9 – Mar 11, 2026
- Investigator
- Eric C. Fox
- Observations
- 3
- Pages
- 4
- FEI number
- 3010067148
In short: On March 11, 2026, FDA issued a Form 483 with 3 observations to Seriously Clean, Ltd in Nixa, Missouri (FEI 3010067148) after an inspection that ran Mar 9 – Mar 11, 2026. The investigator was Eric C. Fox.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.6(a)
Measuring equipment was not calibrated at specified intervals…
- 0221 CFR 801.20(a)21 CFR 830
The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet…
- 03ISO 13485:2016 Clause 7.4.1
Records of the results of evaluation of supplier capability or performance…
This inspection in context
Eric C. Fox
3 documents · 2020–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Arizona.
The firmSeriously Clean, Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 801.20(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Seriously Clean, Ltd?
FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Seriously Clean, Ltd?
Eric C. Fox is named on this Form 483, for the inspection of Mar 9 – Mar 11, 2026. Each investigator has a profile showing what they cite most.
When was Seriously Clean, Ltd inspected by FDA?
The inspection ran Mar 9 – Mar 11, 2026, and the Form 483 is dated March 11, 2026.
How do I get the full Form 483 for Seriously Clean, Ltd?
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.