Wells Pharmacy Network LLC
Form 483 issued September 13, 2016 · Ocala, Florida
- Inspection
- Sep 2 – Sep 13, 2016
- Investigator
- Meredith M. Cobb
- Observations
- 6
- Pages
- 3
- FEI number
- 3006228598
In short: On September 13, 2016, FDA issued a Form 483 with 6 observations to Wells Pharmacy Network LLC in Ocala, Florida (FEI 3006228598) after an inspection that ran Sep 2 – Sep 13, 2016. The investigator was Meredith M. Cobb. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
5 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Actionable microbial contamination was present in the ISO 5 area or in adjacent…
- 02
Your firm did not conduct smoke studies of the aseptic processing…
- 03
Your firm continued producing sterile drug products while construction was ongoing within your facility without establishing…
- 04
Your firm produced sterile drug products within the I (1:5)(4) I Clean Room during pressure differential…
This inspection in context
Meredith M. Cobb
3 documents · 2011–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 211.42
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 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?
Meredith M. Cobb is named on this Form 483, for the inspection of Sep 2 – Sep 13, 2016. Each investigator has a profile showing what they cite most.
When was Wells Pharmacy Network LLC inspected by FDA?
The inspection ran Sep 2 – Sep 13, 2016, and the Form 483 is dated September 13, 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.