Quest Products, LLC
Form 483 issued November 7, 2024 · Kent, Washington
- Inspection
- Oct 30 – Nov 7, 2024
- Observations
- 6
- Pages
- 6
- FEI number
- 3007802698
In short: On November 7, 2024, FDA issued a Form 483 with 6 observations to Quest Products, LLC in Kent, Washington (FEI 3007802698) after an inspection that ran Oct 30 – Nov 7, 2024. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Control procedures fail to include tablet or capsule weight variation, disintegration time, adequacy of mixing to…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 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 Quest Products, LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was Quest Products, LLC inspected by FDA?
The inspection ran Oct 30 – Nov 7, 2024, and the Form 483 is dated November 7, 2024.
How do I get the full Form 483 for Quest Products, 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.