QuVa Pharma, Inc.
Form 483 issued October 28, 2024 · Sugar Land, Texas
- Inspection
- Sep 24 – Oct 28, 2024
- Investigator
- Camerson E. Moore
- Observations
- 4
- Pages
- 8
- FEI number
- 3012053582
In short: On October 28, 2024, FDA issued a Form 483 with 4 observations to QuVa Pharma, Inc. in Sugar Land, Texas (FEI 3012053582) after an inspection that ran Sep 24 – Oct 28, 2024. The investigator was Camerson E. Moore. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Complaint records are deficient in that they do not include the…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at QuVa Pharma, Inc.?
FDA listed 4 observations on this Form 483, mostly about production 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 Sep 24 – Oct 28, 2024. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran Sep 24 – Oct 28, 2024, and the Form 483 is dated October 28, 2024.
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.