Allied Medical LLC
Form 483 issued November 8, 2023 · St. Louis, Missouri
- Inspection
- Oct 30 – Nov 8, 2023
- Investigators
- Clifford F. Long· Edward E. Lockwood
- Observations
- 7
- Pages
- 10
- FEI number
- 1924066
In short: On November 8, 2023, FDA issued a Form 483 with 7 observations to Allied Medical LLC in St. Louis, Missouri (FEI 1924066) after an inspection that ran Oct 30 – Nov 8, 2023. The investigators were Clifford F. Long and Edward E. Lockwood. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Clifford F. Long
4 documents · 2023–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Missouri.
The firmAllied Medical LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allied Medical LLC?
FDA listed 7 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Allied Medical LLC?
Clifford F. Long and Edward E. Lockwood are named on this Form 483, for the inspection of Oct 30 – Nov 8, 2023. Each investigator has a profile showing what they cite most.
When was Allied Medical LLC inspected by FDA?
The inspection ran Oct 30 – Nov 8, 2023, and the Form 483 is dated November 8, 2023.
How do I get the full Form 483 for Allied Medical 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.