Ethical Nutritional, LLC
Form 483 issued December 5, 2024 · Pomona, California
- Inspection
- Dec 3 – Dec 5, 2024
- Observations
- 7
- Pages
- 6
- FEI number
- 3001452120
In short: On December 5, 2024, FDA issued a Form 483 with 7 observations to Ethical Nutritional, LLC in Pomona, California (FEI 3001452120) after an inspection that ran Dec 3 – Dec 5, 2024. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The number of qualified personnel is inadequate to perform and supervise the manufacture, processing and packing…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
This inspection in context
Questions about this 483
What did FDA find at Ethical Nutritional, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
When was Ethical Nutritional, LLC inspected by FDA?
The inspection ran Dec 3 – Dec 5, 2024, and the Form 483 is dated December 5, 2024.
How do I get the full Form 483 for Ethical Nutritional, 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.