QuVa Pharma, Inc.
Form 483 issued August 18, 2022 · Sugar Land, Texas
- Inspection
- Jul 11 – Aug 18, 2022
- Investigator
- Camerson E. Moore
- Observations
- 3
- Pages
- 3
- FEI number
- 3012053582
In short: On August 18, 2022, FDA issued a Form 483 with 3 observations to QuVa Pharma, Inc. in Sugar Land, Texas (FEI 3012053582) after an inspection that ran Jul 11 – Aug 18, 2022. The investigator was Camerson E. Moore. 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 observation- 01
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 02
Determinations of conformance to appropriate written specifications for acceptance are…
- 03
The written stability testing…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmQuVa Pharma, Inc. history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at QuVa Pharma, Inc.?
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 QuVa Pharma, Inc.?
Camerson E. Moore is named on this Form 483, for the inspection of Jul 11 – Aug 18, 2022. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran Jul 11 – Aug 18, 2022, and the Form 483 is dated August 18, 2022.
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.