NuVision Pharmacy, Inc.
Form 483 issued April 17, 2013 · Dallas, Texas
- Inspection
- Apr 2 – Apr 8, 2013
- Investigators
- Jamillah Selby· John T. Chapman· Stephen D. Brown
- Observations
- 12
- Pages
- 11
- FEI number
- 3010087152
In short: On April 17, 2013, FDA issued a Form 483 with 12 observations to NuVision Pharmacy, Inc. in Dallas, Texas (FEI 3010087152) after an inspection that ran Apr 2 – Apr 8, 2013. The investigators were Jamillah Selby, John T. Chapman and Stephen D. Brown. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and laboratory controls account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
There is no written testing program designed to assess the stability…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jamillah Selby
7 documents · 2013–2024
Cites 211.42(c)(10)(iv) (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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NuVision Pharmacy, Inc.?
FDA listed 12 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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.?
Jamillah Selby, John T. Chapman and Stephen D. Brown are named on this Form 483, for the inspection of Apr 2 – Apr 8, 2013. Each investigator has a profile showing what they cite most.
When was NuVision Pharmacy, Inc. inspected by FDA?
The inspection ran Apr 2 – Apr 8, 2013, and the Form 483 is dated April 17, 2013.
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.