NuVision Pharmacy, Inc.
Form 483 issued October 9, 2015 · Dallas, Texas
- Inspection
- Sep 14 – Oct 9, 2015
- Investigators
- Jeffrey D. Meng· Jenny Agila Sefen· Patrice S. Hall
- Observations
- 14
- Pages
- 14
- FEI number
- 3010087152
In short: On October 9, 2015, FDA issued a Form 483 with 14 observations to NuVision Pharmacy, Inc. in Dallas, Texas (FEI 3010087152) after an inspection that ran Sep 14 – Oct 9, 2015. The investigators were Jeffrey D. Meng, Jenny Agila Sefen and Patrice S. Hall. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batdt or…
- 02
Procedures designed to prevent microbiological contamination ofdJug products purporting to be sterile do not include adequate…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Jeffrey D. Meng
14 documents · 2010–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
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 14 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected NuVision Pharmacy, Inc.?
Jeffrey D. Meng, Jenny Agila Sefen and Patrice S. Hall are named on this Form 483, for the inspection of Sep 14 – Oct 9, 2015. Each investigator has a profile showing what they cite most.
When was NuVision Pharmacy, Inc. inspected by FDA?
The inspection ran Sep 14 – Oct 9, 2015, and the Form 483 is dated October 9, 2015.
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.