QuVa Pharma, Inc.
Amended 483 issued March 12, 2016 · Sugar Land, Texas
- Inspection
- Jan 20 – Feb 8, 2016
- Investigators
- Darla J. Christopher· Stephen D. Brown
- Observations
- 5
- Pages
- 5
- FEI number
- 3012053582
In short: On March 12, 2016, FDA issued a Amended 483 with 5 observations to QuVa Pharma, Inc. in Sugar Land, Texas (FEI 3012053582) after an inspection that ran Jan 20 – Feb 8, 2016. The investigators were Darla J. Christopher and Stephen D. Brown. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.192 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
1 more observation
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Darla J. Christopher
10 documents · 2010–2020
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 documentsOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at QuVa Pharma, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment 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.?
Darla J. Christopher and Stephen D. Brown are named on this Amended 483, for the inspection of Jan 20 – Feb 8, 2016. Each investigator has a profile showing what they cite most.
When was QuVa Pharma, Inc. inspected by FDA?
The inspection ran Jan 20 – Feb 8, 2016, and the Amended 483 is dated March 12, 2016.
How do I get the full Amended 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.