CC Wellness, LLC
Form 483 issued November 15, 2023 · Valencia, California
- Observations
- 5
- Pages
- 7
- FEI number
- 3013395518
In short: On November 15, 2023, FDA issued a Form 483 with 5 observations to CC Wellness, LLC in Valencia, California (FEI 3013395518). Most observations concern quality system and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Questions about this 483
What did FDA find at CC Wellness, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
When was CC Wellness, LLC inspected by FDA?
This Form 483 is dated November 15, 2023.
How do I get the full Form 483 for CC Wellness, 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.