Veltek Associates, Inc.
Form 483 issued February 6, 2025 · Malvern, Pennsylvania
- Observations
- 1
- Pages
- 2
- FEI number
- 3001342291
In short: On February 6, 2025, FDA issued a Form 483 with 1 observation to Veltek Associates, Inc. in Malvern, Pennsylvania (FEI 3001342291). Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, specificity and reproducibility of test methods have not…
This inspection in context
Questions about this 483
What did FDA find at Veltek Associates, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
When was Veltek Associates, Inc. inspected by FDA?
This Form 483 is dated February 6, 2025.
How do I get the full Form 483 for Veltek Associates, Inc.?
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.