Wells Pharmacy Network LLC
Form 483 issued July 26, 2013 · Ocala, Florida
- Inspection
- Jul 22 – Jul 26, 2013
- Investigators
- Carla A. Norris· Ileana Barreto-Pettit· Randall L. Morris
- Observations
- 11
- Pages
- 8
- FEI number
- 3006228598
In short: On July 26, 2013, FDA issued a Form 483 with 11 observations to Wells Pharmacy Network LLC in Ocala, Florida (FEI 3006228598) after an inspection that ran Jul 22 – Jul 26, 2013. The investigators were Carla A. Norris, Ileana Barreto-Pettit and Randall L. Morris. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 11 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Carla A. Norris
3 documents · 2013–2014
Cites 211.42 (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, production 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 Wells Pharmacy Network LLC?
Carla A. Norris, Ileana Barreto-Pettit and Randall L. Morris are named on this Form 483, for the inspection of Jul 22 – Jul 26, 2013. Each investigator has a profile showing what they cite most.
When was Wells Pharmacy Network LLC inspected by FDA?
The inspection ran Jul 22 – Jul 26, 2013, and the Form 483 is dated July 26, 2013.
How do I get the full Form 483 for Wells Pharmacy Network LLC?
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