Wells Pharmacy Network, LLC
Form 483 issued April 27, 2018 · Dyersburg, Tennessee
- Inspection
- Apr 16 – Apr 27, 2018
- Investigators
- June P. Page· Pallavi K. Lele
- Observations
- 13
- Pages
- 19
- FEI number
- 3011761321
In short: On April 27, 2018, FDA issued a Form 483 with 13 observations to Wells Pharmacy Network, LLC in Dyersburg, Tennessee (FEI 3011761321) after an inspection that ran Apr 16 – Apr 27, 2018. The investigators were June P. Page and Pallavi K. Lele. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 9 of 13 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 03
The flow of components, diug product containers, closures and diug products though the building is not…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
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 13 observations on this Form 483, mostly about facilities & equipment, quality system 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?
June P. Page and Pallavi K. Lele are named on this Form 483, for the inspection of Apr 16 – Apr 27, 2018. Each investigator has a profile showing what they cite most.
When was Wells Pharmacy Network, LLC inspected by FDA?
The inspection ran Apr 16 – Apr 27, 2018, and the Form 483 is dated April 27, 2018.
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.