AVEM Labs LLC
Form 483 issued May 21, 2025
- Inspection
- May 13 – May 21, 2025
- Investigators
- Garrad R. Poole· Laurissa S. Flowers
- Observations
- 5
- Pages
- 4
- FEI number
- 3017596057
In short: On May 21, 2025, FDA issued a Form 483 with 5 observations to AVEM Labs LLC (FEI 3017596057) after an inspection that ran May 13 – May 21, 2025. The investigators were Garrad R. Poole and Laurissa S. Flowers. Most observations concern hCT/P.
At a glance
5 of 5 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Processes with results which could not be fully verified by inspection and tests, were not validated…
- 02
Labeling procedures did not include…
- 03
Equipment used for measuring was not calibrated…
- 04
Documentation of the receipt of…
This inspection in context
Questions about this 483
What did FDA find at AVEM Labs LLC?
FDA listed 5 observations on this Form 483, mostly about hCT/P. The opening words of each observation are shown on this page.
Who inspected AVEM Labs LLC?
Garrad R. Poole and Laurissa S. Flowers are named on this Form 483, for the inspection of May 13 – May 21, 2025. Each investigator has a profile showing what they cite most.
When was AVEM Labs LLC inspected by FDA?
The inspection ran May 13 – May 21, 2025, and the Form 483 is dated May 21, 2025.
How do I get the full Form 483 for AVEM Labs 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.