QuVa Pharma, Inc.
Form 483 issued May 31, 2019 · Bl oomsbury, New Jersey
- Inspection
- May 7 – May 31, 2019
- Investigator
- Guerlain Ulysse
- Observations
- 6
- Pages
- 4
- FEI number
- 3013931875
In short: On May 31, 2019, FDA issued a Form 483 with 6 observations to QuVa Pharma, Inc. in Bl oomsbury, New Jersey (FEI 3013931875) after an inspection that ran May 7 – May 31, 2019. The investigator was Guerlain Ulysse. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 02
Written records of investigation of a drug complaint do not include the find ings of the…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Aseptic processing areas are deficient regarding the system…
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 firmQuVa Pharma, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at QuVa Pharma, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected QuVa Pharma, Inc.?
Guerlain Ulysse is named on this Form 483, for the inspection of May 7 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran May 7 – May 31, 2019, and the Form 483 is dated May 31, 2019.
How do I get the full Form 483 for QuVa Pharma, Inc.?
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.