Wells Pharmacy Network, LLC
Form 483 issued October 20, 2016 · Dyersburg, Tennessee
- Inspection
- Sep 12 – Oct 20, 2016
- Investigators
- Abby L. Mozeke-Baker· June P. Page
- Observations
- 6
- Pages
- 3
- FEI number
- 3011761321
In short: On October 20, 2016, FDA issued a Form 483 with 6 observations to Wells Pharmacy Network, LLC in Dyersburg, Tennessee (FEI 3011761321) after an inspection that ran Sep 12 – Oct 20, 2016. The investigators were Abby L. Mozeke-Baker and June P. Page. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 5 of 6 observations.
Most cited: 21 CFR 211.113 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the processing of a dmg products are not maintained in a…
- 02
Non-depyrogenated containers were used in drug production. Your drug product containers were not processed to remove…
- 03
The flow of drug products through the building is not…
- 04
The use ofthe sporicidal agent in…
This inspection in context
Abby L. Mozeke-Baker
3 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmWells Pharmacy Network, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wells Pharmacy Network, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Wells Pharmacy Network, LLC?
Abby L. Mozeke-Baker and June P. Page are named on this Form 483, for the inspection of Sep 12 – Oct 20, 2016. Each investigator has a profile showing what they cite most.
When was Wells Pharmacy Network, LLC inspected by FDA?
The inspection ran Sep 12 – Oct 20, 2016, and the Form 483 is dated October 20, 2016.
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.