QuVa Pharma, Inc.
Form 483 issued April 23, 2019 · Sugar Land, Texas
- Inspection
- Apr 5 – Apr 23, 2019
- Investigator
- Camerson E. Moore
- Observations
- 6
- Pages
- 4
- FEI number
- 3012053582
In short: On April 23, 2019, FDA issued a Form 483 with 6 observations to QuVa Pharma, Inc. in Sugar Land, Texas (FEI 3012053582) after an inspection that ran Apr 5 – Apr 23, 2019. The investigator was Camerson E. Moore. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment for adequate control over air pressure, humidity and temperature is not provided when appropriate for…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 04
Investigations of a failure of a batch or any of its components to meet any of…
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 211.192
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 facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). 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 Apr 5 – Apr 23, 2019. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran Apr 5 – Apr 23, 2019, and the Form 483 is dated April 23, 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.