Amneal Pharmaceuticals of New York, LLC
Form 483 issued June 7, 2023 · Brookhaven, New York
- Inspection
- May 22 – Jun 7, 2023
- Investigator
- Miral B. Patel
- Observations
- 5
- Pages
- 7
- FEI number
- 3005263655
In short: On June 7, 2023, FDA issued a Form 483 with 5 observations to Amneal Pharmaceuticals of New York, LLC in Brookhaven, New York (FEI 3005263655) after an inspection that ran May 22 – Jun 7, 2023. The investigator was Miral B. Patel. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Routine calibration of automatic equipment is not performed according to a written program designed…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Miral B. Patel
2 documents · 2023–2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmAmneal Pharmaceuticals of New York, LLC history
The site's inspection history, in date order.
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 of New York, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals of New York, LLC?
Miral B. Patel is named on this Form 483, for the inspection of May 22 – Jun 7, 2023. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals of New York, LLC inspected by FDA?
The inspection ran May 22 – Jun 7, 2023, and the Form 483 is dated June 7, 2023.
How do I get the full Form 483 for Amneal Pharmaceuticals of New York, 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.