Padagis US LLC
Form 483 issued September 6, 2024 · Minneapolis, Minnesota
- Investigator
- Beatrix D. Hippe
- Observations
- 1
- Pages
- 2
- FEI number
- 2127022
In short: On September 6, 2024, FDA issued a Form 483 with 1 observation to Padagis US LLC in Minneapolis, Minnesota (FEI 2127022). The investigator was Beatrix D. Hippe. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(b)(6) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
This inspection in context
Beatrix D. Hippe
4 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmPadagis US LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)(6)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Padagis US LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Padagis US LLC?
Beatrix D. Hippe is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Padagis US LLC inspected by FDA?
This Form 483 is dated September 6, 2024.
How do I get the full Form 483 for Padagis US 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.