XL PRECISION TECHNOLOGIES LTD
Form 483 issued August 29, 2025
- Inspection
- Aug 26 – Aug 29, 2025
- Investigator
- Joshua J. Silvestri
- Observations
- 3
- Pages
- 6
- FEI number
- 3008034554
In short: On August 29, 2025, FDA issued a Form 483 with 3 observations to XL PRECISION TECHNOLOGIES LTD (FEI 3008034554) after an inspection that ran Aug 26 – Aug 29, 2025. The investigator was Joshua J. Silvestri. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures for monitoring and control of process parameters for a validated process have…
This inspection in context
Joshua J. Silvestri
8 documents · 2019–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Georgia.
The firmXL PRECISION TECHNOLOGIES LTD history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at XL PRECISION TECHNOLOGIES LTD?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected XL PRECISION TECHNOLOGIES LTD?
Joshua J. Silvestri is named on this Form 483, for the inspection of Aug 26 – Aug 29, 2025. Each investigator has a profile showing what they cite most.
When was XL PRECISION TECHNOLOGIES LTD inspected by FDA?
The inspection ran Aug 26 – Aug 29, 2025, and the Form 483 is dated August 29, 2025.
How do I get the full Form 483 for XL PRECISION TECHNOLOGIES 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.