MaxPax, LLC
Form 483 issued July 25, 2019 · Elkhorn, Wisconsin
- Inspection
- Jul 22 – Jul 25, 2019
- Investigators
- Ana P. Sandee· Michele L. Glendenning
- Observations
- 2
- Pages
- 4
- FEI number
- 3130094
In short: On July 25, 2019, FDA issued a Form 483 with 2 observations to MaxPax, LLC in Elkhorn, Wisconsin (FEI 3130094) after an inspection that ran Jul 22 – Jul 25, 2019. The investigators were Ana P. Sandee and Michele L. Glendenning. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity…
This inspection in context
Ana P. Sandee
6 documents · 2019–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
The firmMaxPax, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MaxPax, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected MaxPax, LLC?
Ana P. Sandee and Michele L. Glendenning are named on this Form 483, for the inspection of Jul 22 – Jul 25, 2019. Each investigator has a profile showing what they cite most.
When was MaxPax, LLC inspected by FDA?
The inspection ran Jul 22 – Jul 25, 2019, and the Form 483 is dated July 25, 2019.
How do I get the full Form 483 for MaxPax, 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.