Leading Pharma, LLC
Form 483 issued February 29, 2016 · Fairfield, New Jersey
- Inspection
- Feb 25 – Feb 29, 2016
- Investigators
- Guerlain Ulysse· Niketa Patel· Yvesna Blaise
- Observations
- 3
- Pages
- 3
- FEI number
- 3001611969
In short: On February 29, 2016, FDA issued a Form 483 with 3 observations to Leading Pharma, LLC in Fairfield, New Jersey (FEI 3001611969) after an inspection that ran Feb 25 – Feb 29, 2016. The investigators were Guerlain Ulysse, Niketa Patel and Yvesna Blaise. Most observations concern laboratory controls and quality system.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of…
- 02
Established test procedures are…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLeading Pharma, 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 Leading Pharma, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Leading Pharma, LLC?
Guerlain Ulysse, Niketa Patel and Yvesna Blaise are named on this Form 483, for the inspection of Feb 25 – Feb 29, 2016. Each investigator has a profile showing what they cite most.
When was Leading Pharma, LLC inspected by FDA?
The inspection ran Feb 25 – Feb 29, 2016, and the Form 483 is dated February 29, 2016.
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.