QuVa Pharma, Inc.
Form 483 issued November 30, 2017 · Bloomsbury, New Jersey
- Inspection
- Nov 14 – Nov 30, 2017
- Investigators
- Tonia F. Bernard· Zakaria I. Ganiyu
- Observations
- 2
- Pages
- 2
- FEI number
- 3013931875
In short: On November 30, 2017, FDA issued a Form 483 with 2 observations to QuVa Pharma, Inc. in Bloomsbury, New Jersey (FEI 3013931875) after an inspection that ran Nov 14 – Nov 30, 2017. The investigators were Tonia F. Bernard and Zakaria I. Ganiyu. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.56(b) (1×) · 211.188(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures for sanitation…
- 02
The batch production and control records are deficient in that they are not an accurate reproduction…
This inspection in context
Tonia F. Bernard
13 documents · 2016–2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The 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 211.56(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at QuVa Pharma, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected QuVa Pharma, Inc.?
Tonia F. Bernard and Zakaria I. Ganiyu are named on this Form 483, for the inspection of Nov 14 – Nov 30, 2017. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran Nov 14 – Nov 30, 2017, and the Form 483 is dated November 30, 2017.
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.