Medspira, Lie
Form 483 issued January 16, 2024 · Minneapolis, Minnesota
- Inspection
- Dec 27, 2023 – Jan 16, 2024
- Investigator
- Mildred J. Tures
- Observations
- 1
- Pages
- 22
- FEI number
- 3008414621
In short: On January 16, 2024, FDA issued a Form 483 with 1 observation to Medspira, Lie in Minneapolis, Minnesota (FEI 3008414621) after an inspection that ran Dec 27, 2023 – Jan 16, 2024. The investigator was Mildred J. Tures. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(j) (1×) · 21 CFR 820 (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.30(j)21 CFR 820
The design history file does not demonstrate that the design was developed following the requirements…
This inspection in context
Mildred J. Tures
1 document · 2024
Cites 820 more than any other section. Most of their documents are for sites in Minnesota.
The firmMedspira, Lie history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medspira, Lie?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Medspira, Lie?
Mildred J. Tures is named on this Form 483, for the inspection of Dec 27, 2023 – Jan 16, 2024. Each investigator has a profile showing what they cite most.
When was Medspira, Lie inspected by FDA?
The inspection ran Dec 27, 2023 – Jan 16, 2024, and the Form 483 is dated January 16, 2024.
How do I get the full Form 483 for Medspira, Lie?
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.