Wells Pharmacy Network LLC
Form 483 issued March 7, 2014 · Ocala, Florida
- Inspection
- Feb 21 – Mar 7, 2014
- Investigators
- Gene R. Gunn· Nicole E. Knowlton
- Observations
- 11
- Pages
- 6
- FEI number
- 3006228598
In short: On March 7, 2014, FDA issued a Form 483 with 11 observations to Wells Pharmacy Network LLC in Ocala, Florida (FEI 3006228598) after an inspection that ran Feb 21 – Mar 7, 2014. The investigators were Gene R. Gunn and Nicole E. Knowlton. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Gene R. Gunn
1 document · 2014
Cites 211.42(c)(10)(iii) (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmWells Pharmacy Network LLC history
All 6 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 Wells Pharmacy Network LLC?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 Wells Pharmacy Network LLC?
Gene R. Gunn and Nicole E. Knowlton are named on this Form 483, for the inspection of Feb 21 – Mar 7, 2014. Each investigator has a profile showing what they cite most.
When was Wells Pharmacy Network LLC inspected by FDA?
The inspection ran Feb 21 – Mar 7, 2014, and the Form 483 is dated March 7, 2014.
How do I get the full Form 483 for Wells Pharmacy Network LLC?
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.