QuVa Pharma, Inc.
Form 483 issued April 4, 2025 · Bloomsbury, New Jersey
- Inspection
- Mar 25 – Apr 4, 2025
- Investigator
- Logan T. Williams
- Observations
- 5
- Pages
- 7
- FEI number
- 3013931875
In short: On April 4, 2025, FDA issued a Form 483 with 5 observations to QuVa Pharma, Inc. in Bloomsbury, New Jersey (FEI 3013931875) after an inspection that ran Mar 25 – Apr 4, 2025. The investigator was Logan T. Williams. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, specificity and reproducibility of test methods…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Written procedures for sanitation…
- 04
The statistical quality control criteria fail to include…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
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 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at QuVa Pharma, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected QuVa Pharma, Inc.?
Logan T. Williams is named on this Form 483, for the inspection of Mar 25 – Apr 4, 2025. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran Mar 25 – Apr 4, 2025, and the Form 483 is dated April 4, 2025.
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.