Leading Pharma, LLC
Form 483 issued October 21, 2024 · Fairfield, New Jersey
- Inspection
- Oct 15 – Oct 21, 2024
- Observations
- 5
- Pages
- 6
- FEI number
- 3001611969
In short: On October 21, 2024, FDA issued a Form 483 with 5 observations to Leading Pharma, LLC in Fairfield, New Jersey (FEI 3001611969) after an inspection that ran Oct 15 – Oct 21, 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
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
In-process materials are not tested for quality and approved or rejected by the quality control unit…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
Questions about this 483
What did FDA find at Leading Pharma, LLC?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
When was Leading Pharma, LLC inspected by FDA?
The inspection ran Oct 15 – Oct 21, 2024, and the Form 483 is dated October 21, 2024.
How do I get the full Form 483 for Leading Pharma, 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.