American Spraytech, LLC
Form 483 issued January 24, 2025 · North Branch, New Jersey
- Inspection
- Jan 21 – Jan 24, 2025
- Investigator
- Ronda R. Loyd Jones
- Observations
- 3
- Pages
- 10
- FEI number
- 3004380247
In short: On January 24, 2025, FDA issued a Form 483 with 3 observations to American Spraytech, LLC in North Branch, New Jersey (FEI 3004380247) after an inspection that ran Jan 21 – Jan 24, 2025. The investigator was Ronda R. Loyd Jones. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and…
- 02
The written record did not include the reason an investigation was found not to be necessary…
- 03
Input to and output from the computer, related systems of formulas and records or data are…
This inspection in context
Ronda R. Loyd Jones
7 documents · 2025–2026
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Arizona.
The firmAmerican Spraytech, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Spraytech, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected American Spraytech, LLC?
Ronda R. Loyd Jones is named on this Form 483, for the inspection of Jan 21 – Jan 24, 2025. Each investigator has a profile showing what they cite most.
When was American Spraytech, LLC inspected by FDA?
The inspection ran Jan 21 – Jan 24, 2025, and the Form 483 is dated January 24, 2025.
How do I get the full Form 483 for American Spraytech, 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.