Amneal Pharmaceuticals, LLC
Form 483 issued February 21, 2019 · Branchburg, New Jersey
- Inspection
- Feb 5 – Feb 21, 2019
- Investigator
- James R. Birkenstamm
- Observations
- 3
- Pages
- 5
- FEI number
- 3004488497
In short: On February 21, 2019, FDA issued a Form 483 with 3 observations to Amneal Pharmaceuticals, LLC in Branchburg, New Jersey (FEI 3004488497) after an inspection that ran Feb 5 – Feb 21, 2019. The investigator was James R. Birkenstamm. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
This inspection in context
James R. Birkenstamm
12 documents · 2018–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
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 211.192
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 quality system, materials and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals, LLC?
James R. Birkenstamm is named on this Form 483, for the inspection of Feb 5 – Feb 21, 2019. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals, LLC inspected by FDA?
The inspection ran Feb 5 – Feb 21, 2019, and the Form 483 is dated February 21, 2019.
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.