American Spraytech, LLC
Form 483 issued April 11, 2024 · North Branch, New Jersey
- Inspection
- Apr 1 – Apr 11, 2024
- Investigator
- Naakesh N. Gomanie
- Observations
- 2
- Pages
- 3
- FEI number
- 3004380247
In short: On April 11, 2024, FDA issued a Form 483 with 2 observations to American Spraytech, LLC in North Branch, New Jersey (FEI 3004380247) after an inspection that ran Apr 1 – Apr 11, 2024. The investigator was Naakesh N. Gomanie. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.90(a) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
- 02
Procedures for corrective and preventive action have…
This inspection in context
Naakesh N. Gomanie
3 documents · 2023–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
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 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Spraytech, LLC?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected American Spraytech, LLC?
Naakesh N. Gomanie is named on this Form 483, for the inspection of Apr 1 – Apr 11, 2024. Each investigator has a profile showing what they cite most.
When was American Spraytech, LLC inspected by FDA?
The inspection ran Apr 1 – Apr 11, 2024, and the Form 483 is dated April 11, 2024.
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.