Phillips-Medisize, LLC
Form 483 issued March 6, 2025 · Menomonie, Wisconsin
- Inspection
- Mar 3 – Mar 6, 2025
- Observations
- 4
- Pages
- 5
- FEI number
- 3002919960
In short: On March 6, 2025, FDA issued a Form 483 with 4 observations to Phillips-Medisize, LLC in Menomonie, Wisconsin (FEI 3002919960) after an inspection that ran Mar 3 – Mar 6, 2025. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Complaint records are deficient in that they do not include the…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Questions about this 483
What did FDA find at Phillips-Medisize, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was Phillips-Medisize, LLC inspected by FDA?
The inspection ran Mar 3 – Mar 6, 2025, and the Form 483 is dated March 6, 2025.
How do I get the full Form 483 for Phillips-Medisize, 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.