Allied Medical LLC
Form 483 issued May 20, 2022 · St. Louis, Missouri
- Inspection
- Apr 19 – May 20, 2022
- Investigator
- Edward E. Lockwood
- Observations
- 16
- Pages
- 16
- FEI number
- 1924066
In short: On May 20, 2022, FDA issued a Form 483 with 16 observations to Allied Medical LLC in St. Louis, Missouri (FEI 1924066) after an inspection that ran Apr 19 – May 20, 2022. The investigator was Edward E. Lockwood. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by production & process controls.
Most cited: 21 CFR 820.30 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures have not been adequately established to control product that does not…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Edward E. Lockwood
5 documents · 2018–2024
Cites 820.100 (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 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allied Medical LLC?
FDA listed 16 observations on this Form 483, mostly about production & process controls, cAPA and 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 Allied Medical LLC?
Edward E. Lockwood is named on this Form 483, for the inspection of Apr 19 – May 20, 2022. Each investigator has a profile showing what they cite most.
When was Allied Medical LLC inspected by FDA?
The inspection ran Apr 19 – May 20, 2022, and the Form 483 is dated May 20, 2022.
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.