KDL Precision Molding
Form 483 issued February 7, 2019 · Pacoima, California
- Inspection
- Feb 5 – Feb 7, 2019
- Investigator
- Kelvin Cheung
- Observations
- 2
- Pages
- 4
- FEI number
- 3002941807
In short: On February 7, 2019, FDA issued a Form 483 with 2 observations to KDL Precision Molding in Pacoima, California (FEI 3002941807) after an inspection that ran Feb 5 – Feb 7, 2019. The investigator was Kelvin Cheung. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(c) (1×) · 820.120 (1×)
What FDA observed
Preview: the opening words of each observation- 01
A validated process was not reviewed and evaluated and revalidated when changes or process deviations occurred…
- 02
Procedures to control labeling activities…
This inspection in context
Kelvin Cheung
5 documents · 2008–2021
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in California.
The firmKDL Precision Molding history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KDL Precision Molding?
FDA listed 2 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected KDL Precision Molding?
Kelvin Cheung is named on this Form 483, for the inspection of Feb 5 – Feb 7, 2019. Each investigator has a profile showing what they cite most.
When was KDL Precision Molding inspected by FDA?
The inspection ran Feb 5 – Feb 7, 2019, and the Form 483 is dated February 7, 2019.
How do I get the full Form 483 for KDL Precision Molding?
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.