Americanna Wellness Inc
Form 483 issued October 28, 2024 · BELLINGHAM, Washington
- Inspection
- Oct 24 – Oct 28, 2024
- Observations
- 5
- Pages
- 4
- FEI number
- 3026572519
In short: On October 28, 2024, FDA issued a Form 483 with 5 observations to Americanna Wellness Inc in BELLINGHAM, Washington (FEI 3026572519) after an inspection that ran Oct 24 – Oct 28, 2024. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Questions about this 483
What did FDA find at Americanna Wellness Inc?
FDA listed 5 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
When was Americanna Wellness Inc inspected by FDA?
The inspection ran Oct 24 – Oct 28, 2024, and the Form 483 is dated October 28, 2024.
How do I get the full Form 483 for Americanna Wellness Inc?
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.