Suretec Innovations LLC
Form 483 issued March 5, 2026
- Inspection
- Mar 2 – Mar 5, 2026
- Investigator
- Jeffrey T. Prosterman
- Observations
- 4
- Pages
- 5
- FEI number
- 3030456591
In short: On March 5, 2026, FDA issued a Form 483 with 4 observations to Suretec Innovations LLC (FEI 3030456591) after an inspection that ran Mar 2 – Mar 5, 2026. The investigator was Jeffrey T. Prosterman. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.22 (2×) · 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Jeffrey T. Prosterman
5 documents · 2025–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Arizona.
The firmSuretec Innovations 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Suretec Innovations LLC?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Suretec Innovations LLC?
Jeffrey T. Prosterman is named on this Form 483, for the inspection of Mar 2 – Mar 5, 2026. Each investigator has a profile showing what they cite most.
When was Suretec Innovations LLC inspected by FDA?
The inspection ran Mar 2 – Mar 5, 2026, and the Form 483 is dated March 5, 2026.
How do I get the full Form 483 for Suretec Innovations 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.