American Contract Systems Jackson Pointe Commerce, 4050 Jacksons
Form 483 issued July 25, 2019 · Zelienople, Pennsylvania
- Inspection
- Jul 10 – Jul 25, 2019
- Investigator
- Katelyn A. Staub-Zamperini
- Observations
- 1
- Pages
- 9
- FEI number
- 3011389083
In short: On July 25, 2019, FDA issued a Form 483 with 1 observation to American Contract Systems Jackson Pointe Commerce, 4050 Jacksons in Zelienople, Pennsylvania (FEI 3011389083) after an inspection that ran Jul 10 – Jul 25, 2019. The investigator was Katelyn A. Staub-Zamperini. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Katelyn A. Staub-Zamperini
7 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAmerican Contract Systems Jackson Pointe Commerce, 4050 Jacksons history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Contract Systems Jackson Pointe Commerce, 4050 Jacksons?
FDA listed 1 observation 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 American Contract Systems Jackson Pointe Commerce, 4050 Jacksons?
Katelyn A. Staub-Zamperini is named on this Form 483, for the inspection of Jul 10 – Jul 25, 2019. Each investigator has a profile showing what they cite most.
When was American Contract Systems Jackson Pointe Commerce, 4050 Jacksons inspected by FDA?
The inspection ran Jul 10 – Jul 25, 2019, and the Form 483 is dated July 25, 2019.
How do I get the full Form 483 for American Contract Systems Jackson Pointe Commerce, 4050 Jacksons?
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