Variamed, LLC
Form 483 issued December 18, 2024 · Chattanooga, Tennessee
- Inspection
- Dec 17 – Dec 18, 2024
- Investigators
- Jamie P. Webb· Lashawn M. Elam
- Observations
- 12
- Pages
- 6
- FEI number
- 3010405322
In short: On December 18, 2024, FDA issued a Form 483 with 12 observations to Variamed, LLC in Chattanooga, Tennessee (FEI 3010405322) after an inspection that ran Dec 17 – Dec 18, 2024. The investigators were Jamie P. Webb and Lashawn M. Elam. Most observations concern production & process controls and cAPA.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procediues to ensrue that all purchased or otherwise received product and services conform to specified requir…
- 03
Procediues for corrective and preventive action…
- 04
Procediues for acceptance activities…
This inspection in context
Jamie P. Webb
2 documents · 2024–2026
Cites 820 more than any other section. Most of their documents are for sites in Tennessee.
The firmVariamed, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Variamed, LLC?
FDA listed 12 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected Variamed, LLC?
Jamie P. Webb and Lashawn M. Elam are named on this Form 483, for the inspection of Dec 17 – Dec 18, 2024. Each investigator has a profile showing what they cite most.
When was Variamed, LLC inspected by FDA?
The inspection ran Dec 17 – Dec 18, 2024, and the Form 483 is dated December 18, 2024.
How do I get the full Form 483 for Variamed, 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.