Jungle Jim's Pharmacy
Form 483 issued January 26, 2015 · Fairfield, Ohio
- Inspection
- Jan 12 – Jan 26, 2015
- Investigator
- Joshua P. Wireman
- Observations
- 3
- Pages
- 3
- FEI number
- 3011299928
In short: On January 26, 2015, FDA issued a Form 483 with 3 observations to Jungle Jim's Pharmacy in Fairfield, Ohio (FEI 3011299928) after an inspection that ran Jan 12 – Jan 26, 2015. The investigator was Joshua P. Wireman. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
There is no written testing program designed to assess the stability…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Joshua P. Wireman
8 documents · 2015–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmJungle Jim's Pharmacy history
All 2 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 Jungle Jim's Pharmacy?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Jungle Jim's Pharmacy?
Joshua P. Wireman is named on this Form 483, for the inspection of Jan 12 – Jan 26, 2015. Each investigator has a profile showing what they cite most.
When was Jungle Jim's Pharmacy inspected by FDA?
The inspection ran Jan 12 – Jan 26, 2015, and the Form 483 is dated January 26, 2015.
How do I get the full Form 483 for Jungle Jim's Pharmacy?
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.