Amneal Pharmaceuticals, Llc
Form 483 issued October 25, 2017 · Paterson, New Jersey
- Inspection
- Oct 16 – Oct 25, 2017
- Investigators
- Helen Verdel· Yvins Dezan
- Observations
- 5
- Pages
- 4
- FEI number
- 3003792057
In short: On October 25, 2017, FDA issued a Form 483 with 5 observations to Amneal Pharmaceuticals, Llc in Paterson, New Jersey (FEI 3003792057) after an inspection that ran Oct 16 – Oct 25, 2017. The investigators were Helen Verdel and Yvins Dezan. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
4 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
- 03
Routine calibration of electronic equipment is not performed according to a written program designed…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmAmneal Pharmaceuticals, Llc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Pharmaceuticals, Llc?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals, Llc?
Helen Verdel and Yvins Dezan are named on this Form 483, for the inspection of Oct 16 – Oct 25, 2017. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals, Llc inspected by FDA?
The inspection ran Oct 16 – Oct 25, 2017, and the Form 483 is dated October 25, 2017.
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.