Wells Pharmacy Network, LLC
Form 483 issued January 28, 2021 · Dyersburg, Tennessee
- Inspection
- Dec 1, 2020 – Jan 28, 2021
- Investigators
- Julius I. Jones· June P. Page
- Observations
- 8
- Pages
- 15
- FEI number
- 3011761321
In short: On January 28, 2021, FDA issued a Form 483 with 8 observations to Wells Pharmacy Network, LLC in Dyersburg, Tennessee (FEI 3011761321) after an inspection that ran Dec 1, 2020 – Jan 28, 2021. The investigators were Julius I. Jones and June P. Page. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 04
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
This inspection in context
Julius I. Jones
1 document · 2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Tennessee.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wells Pharmacy Network, LLC?
FDA listed 8 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Wells Pharmacy Network, LLC?
Julius I. Jones and June P. Page are named on this Form 483, for the inspection of Dec 1, 2020 – Jan 28, 2021. Each investigator has a profile showing what they cite most.
When was Wells Pharmacy Network, LLC inspected by FDA?
The inspection ran Dec 1, 2020 – Jan 28, 2021, and the Form 483 is dated January 28, 2021.
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.