NuVision Pharmacy, Inc.
Form 483 issued November 19, 2018 · Dallas, Texas
- Inspection
- Sep 17 – Nov 19, 2018
- Investigators
- Jason R. Caballero· Scott Ballard
- Observations
- 4
- Pages
- 3
- FEI number
- 3010087152
In short: On November 19, 2018, FDA issued a Form 483 with 4 observations to NuVision Pharmacy, Inc. in Dallas, Texas (FEI 3010087152) after an inspection that ran Sep 17 – Nov 19, 2018. The investigators were Jason R. Caballero and Scott Ballard. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: FDCA 501(a)(2)(A) (3×) · 211.166(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Equipment was not disinfected prior to entering…
- 02FDCA 501(a)(2)(A)
The JSO 5 classified aseptic processing areas had difficult to…
- 03
Resul ts of stabi lity testing are not used in…
- 04FDCA 501(a)(2)(A)
Your facility was designed and/or operated in a way that permits…
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 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 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NuVision Pharmacy, Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected NuVision Pharmacy, Inc.?
Jason R. Caballero and Scott Ballard are named on this Form 483, for the inspection of Sep 17 – Nov 19, 2018. Each investigator has a profile showing what they cite most.
When was NuVision Pharmacy, Inc. inspected by FDA?
The inspection ran Sep 17 – Nov 19, 2018, and the Form 483 is dated November 19, 2018.
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.