Vee Pak LLC
Form 483 issued December 11, 2023 · Countryside, Illinois
- Inspection
- Dec 6 – Dec 11, 2023
- Investigator
- Peng Zhou
- Observations
- 1
- Pages
- 3
- FEI number
- 1421421
In short: On December 11, 2023, FDA issued a Form 483 with 1 observation to Vee Pak LLC in Countryside, Illinois (FEI 1421421) after an inspection that ran Dec 6 – Dec 11, 2023. The investigator was Peng Zhou. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166(a)(3) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The written stability program for drug products does not include reliable…
This inspection in context
Peng Zhou
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmVee Pak LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vee Pak LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Vee Pak LLC?
Peng Zhou is named on this Form 483, for the inspection of Dec 6 – Dec 11, 2023. Each investigator has a profile showing what they cite most.
When was Vee Pak LLC inspected by FDA?
The inspection ran Dec 6 – Dec 11, 2023, and the Form 483 is dated December 11, 2023.
How do I get the full Form 483 for Vee Pak 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.