NuVision Pharmacy, Inc.
Form 483 issued July 16, 2014 · Dallas, Texas
- Inspection
- Jun 3 – Jul 16, 2014
- Investigators
- Darla J. Christopher· Stephen D. Brown
- Observations
- 13
- Pages
- 15
- FEI number
- 3010087152
In short: On July 16, 2014, FDA issued a Form 483 with 13 observations to NuVision Pharmacy, Inc. in Dallas, Texas (FEI 3010087152) after an inspection that ran Jun 3 – Jul 16, 2014. The investigators were Darla J. Christopher and Stephen D. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 8 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly n:view the failure ofa batch or any of its components…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This 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 firmNuVision Pharmacy, Inc. history
All 7 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 NuVision Pharmacy, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected NuVision Pharmacy, Inc.?
Darla J. Christopher and Stephen D. Brown are named on this Form 483, for the inspection of Jun 3 – Jul 16, 2014. Each investigator has a profile showing what they cite most.
When was NuVision Pharmacy, Inc. inspected by FDA?
The inspection ran Jun 3 – Jul 16, 2014, and the Form 483 is dated July 16, 2014.
How do I get the full Form 483 for NuVision Pharmacy, 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.