Amneal Pharmaceuticals, LLC
Form 483 issued November 18, 2022 · Branchburg, New Jersey
- Inspection
- Nov 14 – Nov 18, 2022
- Investigator
- Jogy George
- Observations
- 3
- Pages
- 4
- FEI number
- 3004488497
In short: On November 18, 2022, FDA issued a Form 483 with 3 observations to Amneal Pharmaceuticals, LLC in Branchburg, New Jersey (FEI 3004488497) after an inspection that ran Nov 14 – Nov 18, 2022. The investigator was Jogy George. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written production and process control procedures are…
- 02
There is insufficient physical or spatial separation from operations and other drug products to…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jogy George
15 documents · 2016–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
The firmAmneal Pharmaceuticals, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Pharmaceuticals, LLC?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals, LLC?
Jogy George is named on this Form 483, for the inspection of Nov 14 – Nov 18, 2022. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals, LLC inspected by FDA?
The inspection ran Nov 14 – Nov 18, 2022, and the Form 483 is dated November 18, 2022.
How do I get the full Form 483 for Amneal Pharmaceuticals, 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.