QuVa Pharma, Inc.
Form 483 issued June 2, 2017 · Sugar Land, Texas
- Inspection
- May 23 – Jun 2, 2017
- Investigators
- Jason R. Caballero· Shatina R. Alridge
- Observations
- 1
- Pages
- 2
- FEI number
- 3012053582
In short: On June 2, 2017, FDA issued a Form 483 with 1 observation to QuVa Pharma, Inc. in Sugar Land, Texas (FEI 3012053582) after an inspection that ran May 23 – Jun 2, 2017. The investigators were Jason R. Caballero and Shatina R. Alridge. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) 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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected QuVa Pharma, Inc.?
Jason R. Caballero and Shatina R. Alridge are named on this Form 483, for the inspection of May 23 – Jun 2, 2017. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran May 23 – Jun 2, 2017, and the Form 483 is dated June 2, 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.